Capsid inhibitors for HIV prevention

Abstract

To provide methods of preventing disease.SOLUTION: The present disclosure provides methods of preventing HIV in a subject, comprising administering to the subject a therapeutically effective amount of compounds of Formula (la) or (lb) or a pharmaceutically acceptable salt thereof, optionally in combination with one or more additional therapeutic agents. Methods of reducing the risk of HIV infection, such as HIV-1 and / or HIV-2, are also provided.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] This disclosure provides a method for preventing HIV in a subject, comprising administering to the subject a therapeutically effective dose of an HIV capsid inhibitor, or a pharmaceutically acceptable salt thereof, in combination with one or more additional therapeutic agents, as is optional.

[0002] (Sequence Listing) This disclosure includes a sequence listing submitted electronically in ASCII format, which is incorporated herein by reference in its entirety. The ASCII copy, created on November 16, 2020, is named 1329.P2PC_PF Sequence Listing.txt and is 854 bytes in size. [Background technology]

[0003] The HIV / AIDS pandemic has claimed millions of lives, and millions remain infected. Antiretroviral therapy has made HIV infection a chronic and manageable disease. However, there is still no cure for HIV. Reducing new HIV infections is a global goal. Therefore, prophylactic regimens for both pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) are being investigated. Truvada (emtricitabine-tenofovir disoproxil fumarate) and Descovy (emtricitabine-tenofovir alafenamide) are currently the only drugs approved for PrEP. Therefore, there is a need for new and effective means to prevent HIV infection, and the methods described herein were developed to meet this need. [Overview of the project] [Means for solving the problem]

[0004] This disclosure provides a method for preventing HIV infection in a subject or reducing the risk of HIV infection in a subject, comprising administering a therapeutically effective dose of an HIV capsid inhibitor or a pharmaceutically acceptable salt thereof to the subject in combination with one or more additional therapeutic agents, as is optional.

[0005] This disclosure further provides HIV capsid inhibitors or pharmaceutically acceptable salts thereof for use in any of the methods described herein.

[0006] This disclosure further provides the use of HIV capsid inhibitors or pharmaceutically acceptable salts thereof for preparing pharmaceuticals for use in any of the methods described herein. [Brief explanation of the drawing]

[0007] [Figure 1] This shows a typical scheme illustrating the PrEP test design for Example 1.

[0008] [Figure 2] This shows a typical scheme illustrating the PrEP test design for Example 2.

[0009] [Figure 3] This shows a typical scheme illustrating the PrEP test design for Example 3.

[0010] [Figure 4] This graph shows the pharmacokinetic profile of compound (Ib) ("compound Ib") in male / female rhesus monkeys administered with SHIV antigen, with the study week on the x-axis and the plasma concentration (nM) of compound (Ib) ("compound Ib") on the y-axis.

[0011] [Figure 5]This graph shows the time course of infection in male / female rhesus monkeys after a single subcutaneous administration of the medium or compound of formula (Ib) ("Compound Ib") followed by antigen administration with SHIV, with the X-axis representing the study week and the Y-axis representing the percentage of aviremia.

[0012] [Figure 6A] The graph shows the time course of plasma SHIV viral load in individual male / female rhesus monkeys after a single subcutaneous administration of the medium, followed by weekly rectal antigen administration with gradually increasing SHIV doses. The X-axis represents the week of the study, and the Y-axis represents plasma SHIV (copies / mL).

[0013] [Figure 6B] The graph shows the time course of plasma SHIV viral load in individual male / female rhesus monkeys after a single subcutaneous administration of 150 mg / kg of compound (Ib) ("compound Ib"), followed by weekly rectal antigen administration with gradually increasing SHIV doses. The X-axis represents the week of the study, and the Y-axis represents plasma SHIV (copies / mL).

[0014] [Figure 6C] The graph shows the time course of plasma SHIV viral load in individual male / female rhesus monkeys after a single subcutaneous administration of 300 mg / kg of compound (Ib) ("Compound Ib"), followed by weekly rectal antigen administration with gradually increasing SHIV doses. The X-axis represents the week of the study, and the Y-axis represents plasma SHIV (copies / mL). [Modes for carrying out the invention]

[0015] This disclosure relates to a method for preventing HIV infection (e.g., HIV-1 and / or HIV-2) in a subject (e.g., a human) by administering a therapeutically effective dose of an HIV capsid inhibitor or a pharmaceutically acceptable salt thereof to the subject.

[0016] In some embodiments, the HIV capsid inhibitor (e.g., a compound of formula (Ia) or formula (Ib)), or a pharmaceutically acceptable salt thereof, is administered as a monotherapy (i.e., in the absence of additional therapeutic agents). In some embodiments, the HIV capsid inhibitor (e.g., a compound of formula (Ia) or formula (Ib)), or a pharmaceutically acceptable salt thereof, is administered in combination with one or more additional therapeutic agents such as anti-HIV agents.

[0017] In some embodiments, the HIV capsid inhibitor is a compound of formula (Ia) or formula (Ib):

Chemical formula

[0018] In some embodiments, the method comprises administering a compound of formula (Ia), or a pharmaceutically acceptable salt thereof. In some embodiments, the method comprises administering a compound of formula (Ib), or a pharmaceutically acceptable salt thereof.

[0019] The present disclosure provides a method of using a compound of formula (Ia) having the following structure, N-((S)-1-(3-(4-chloro-3-(methylsulfonamido)-1-(2,2,2-trifluoroethyl)-1H-indazol-7-yl)-6-(3-methyl-3-(methylsulfonyl)but-1-yn-1-yl)pyridin-2-yl)-2-(3,5-difluorophenyl)ethyl)-2-((3bS,4aR)-5,5-difluoro-3-(trifluoromethyl)-3b,4,4a,5-tetrahydro-1H-cyclopropa[3,4]cyclopenta[1,2-c]pyrazol-1-yl)acetamide:

Chemical formula

[0020] This disclosure also relates to formula (Ib), which has the following structure: N-((S)-1-(3-(4-chloro-3-(cyclopropanesulfonamide)-1-(2,2-difluoroethyl)-1H-indazole-7-yl)-6-(3-methyl-3-(methylsulfonyl)buta-1-in-1-yl)pyridine-2-yl)-2-(3,5-difluorophenyl)ethyl)-2-((3bS,4aR)-3-(difluoromethyl)-5,5-difluoro-3b,4,4a,5-tetrahydro-1H-cyclopropa[3,4]cyclopenta[1,2-c]pyrazole-1-yl)acetamide: [ka] Those who use the compound, or a pharmaceutically acceptable salt thereof, for the prevention of HIV infection Including the law.

[0021] The synthesis and characterization of the compounds of formula (Ia) and formula (Ib), as well as their salts, are described in International Publication 2018 / 035359 (see also U.S. Patent Application Publication 20180051005) and International Publication 2019 / 161280, the contents of which are incorporated herein by reference in their entirety. Various forms of the compound of formula (Ia) are disclosed in International Publication 2019 / 035973 (see also U.S. Patent Application Publication 20190083478) and International Publication 2019 / 035904 (see also U.S. Patent Application Publication 20190084963), the contents of which are incorporated herein by reference in their entirety.

[0022] In some embodiments, the HIV capsid inhibitor is a pharmaceutically acceptable salt of the compound of formula (Ia) or formula (Ib). Non-limiting examples of pharmaceutically acceptable salts of the compounds of formula (Ia) and formula (Ib) include sodium salts. In some embodiments, the compound of formula (Ia) is a sodium salt.

[0023] Unless otherwise specified for a particular pharmaceutically acceptable salt and / or solvate of the compound of formula (Ia) or formula (Ib) provided above, any dose, whether expressed in milligrams or weight percent, should be understood to refer to the amount of free acid, i.e., the compound of formula (Ia) or formula (Ib). For example, a reference to "50 mg" of formula (Ia) or its pharmaceutically acceptable salt refers to the amount of formula (Ia) or its pharmaceutically acceptable salt that provides the same amount of formula (Ia) compound as 50 mg of the free acid compound of formula (Ia). In some embodiments, a dose relating to 50 mg of formula (Ia) includes approximately 51.1 mg of the monosodium salt of formula (Ia).

[0024] In some embodiments of the methods disclosed herein, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered in doses ranging from about 10 mg to about 2000 mg. In some embodiments of the methods disclosed herein, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered in doses ranging from about 10 mg to about 3000 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered in doses ranging from about 50 mg, about 100 mg, about 150 mg, about 200 mg, about 250 mg, about 300 mg, about 350 mg, about 400 mg, about 450 mg, about 500 mg, about 550 mg, about 600 mg, about 650 mg, about 700 mg, about 750 mg, about 800 mg, about 850 mg, about 900 mg, about 950 mg, It is administered in doses of approximately 1000 mg, 1050 mg, 1100 mg, 1150 mg, 1200 mg, 1250 mg, 1300 mg, 1350 mg, 1400 mg, 1450 mg, 1500 mg, 1550 mg, 1600 mg, 1650 mg, 1700 mg, 1750 mg, 1800 mg, 1850 mg, 1900 mg, 1950 mg, or 2000 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered in doses of approximately 2050 mg, approximately 2100 mg, approximately 2150 mg, approximately 2200 mg, approximately 2250 mg, approximately 2300 mg, approximately 2350 mg, approximately 2400 mg, approximately 2450 mg, approximately 2500 mg, approximately 2550 mg, approximately 2600 mg, approximately 2650 mg, approximately 2700 mg, approximately 2750 mg, approximately 2800 mg, approximately 2850 mg, approximately 2900 mg, approximately 2950 mg, or approximately 3000 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered in doses of approximately 900 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered in a dose of approximately 500 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered in a dose of approximately 300 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered in a dose of approximately 100 mg.In some embodiments, a compound of formula (Ia) or formula (Ib), or its pharmaceutically acceptable properties. The acceptable dose of salt is administered at a dosage of approximately 50 mg.

[0025] In some embodiments, subjects may have HIV infection or be at risk of developing it. In some embodiments, subjects are identified as individuals at risk of sexually transmitted HIV. In some embodiments, individuals are identified as males (e.g., those who have sexual intercourse with men or women), transgender men, transgender women, women (e.g., those who have sexual intercourse with men or women), and / or sex workers. In some embodiments, individuals are identified as follows: • Having had anal sex with at least two different sexual partners and not consistently using condoms in the past six months, and / or • You have a history of a sexually transmitted infection (STI) in the past 12 months (e.g., syphilis, gonorrhea, chlamydia, HBV or HCV infection), and / or • Using psychotropic drugs (e.g., cocaine, gamma hydroxybutyrate (GHB), methylenedioxymethamphetamine (MDMA), mephedrone) during sexual intercourse, and / or • Having had sexual intercourse with one or more partners from regions with a high HIV prevalence (over 1%) (e.g., South America, Sub-Saharan Africa, Southeast Asia, Eastern Europe, French Guiana), and consistently not using condoms, and / or • Sex workers, and / or • Having a sexual partner who is an intravenous drug user and shares injectable medications, and / or • Having a sexually infected HIV-positive partner with a detectable viral load in plasma (e.g., more than 50 copies (cp) / milliliter (mL)).

[0026] In some embodiments, the subjects are HIV-negative. In some embodiments, HIV is HIV-1. In some embodiments, HIV is HIV-2. In some embodiments, HIV is HIV-1 and HIV-2.

[0027] As used herein, the terms “prevention” or “to prevent” mean administering the compounds, pharmaceutically acceptable salts thereof, or compositions containing the compounds or pharmaceutically acceptable salts thereof according to the Disclosure before exposure to the virus in question, or after exposure but before the onset of symptoms of the disease, and / or before the detection of the virus in the blood. The term also means preventing the onset of symptoms of the disease, and / or preventing the virus from reaching detectable concentrations in the blood. The term includes both pre-exposure prophylaxis (PrEP), post-exposure prophylaxis (PEP), and event-driven or “on-demand” prophylaxis. The term also means preventing perinatal transmission of HIV from mother to infant by administering the compounds, pharmaceutically acceptable salts thereof, or compositions containing the compounds or pharmaceutically acceptable salts thereof to mothers before childbirth and to infants within the first few days of life. The term also means preventing HIV transmission through blood transfusion.

[0028] As used herein, the term “exposure period” refers to a period of time, ranging from a single event to multiple events over a longer period, that exposes a subject to HIV. For example, a subject who has had sexual intercourse with an HIV-positive partner once has an exposure period limited to the time and duration of that single sexual encounter with that partner. As another example, a subject who has had sexual intercourse with an HIV-positive partner multiple times over a longer period (e.g., days, weeks, months, or years) has an exposure period ranging from the first instance to the last instance of sexual intercourse with that partner.

[0029] As used herein, the term "inhibition index" (IQ) refers to the EC of a compound of formula (Ia) or formula (Ib) adjusted for serum protein binding, or a pharmaceutically acceptable salt thereof. 95 It refers to a value.

[0030] In some embodiments, the combination of formula (Ia) or formula (Ib) disclosed herein The substance, or a pharmaceutically acceptable salt thereof, is administered once daily. In some embodiments, the methods disclosed herein involve repeated administration at intervals less than once daily. For example, in certain embodiments, the methods disclosed herein involve administering a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, once every other day, five times a week, four times a week, three times a week, twice a week, once a week, once every two weeks, once every three weeks, once every four weeks, once every five weeks, once every six weeks, once every seven weeks, or once every eight weeks. In some embodiments of the methods disclosed herein, the methods involve administering a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, once a month, once every two months, once every three months, once every four months, once every five months, once every six months, or once a year.

[0031] In some embodiments, the methods disclosed herein involve event-driven administration of a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, to a subject. As used herein, the terms “event-driven” or “event-driven administration” mean administering a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, (1) before an event that exposes the subject to HIV (or otherwise increases the subject's risk of HIV infection) (e.g., 2 hours, 1 day, 2 days, 5 days, 7 days, 10 days, 14 days, 28 days (i.e., 1 month), or more before the event), and / or (2) during an event (or a series of repeated events) that exposes the subject to HIV (or otherwise increases the subject's risk of HIV infection), and / or (3) after an event (or the last event in a series of repeated events) that exposes the subject to HIV (or otherwise increases the subject's risk of HIV infection). In some embodiments, the event-driven administration is performed before the subject's exposure to HIV. In some embodiments, event-driven administration is performed during the subject's exposure to HIV. In some embodiments, event-driven administration is performed after the subject's exposure to HIV.

[0032] In some embodiments, event-driven administration is performed before and during exposure to the target HIV.

[0033] In some embodiments, event-driven administration is performed before and after exposure to HIV.

[0034] In some embodiments, event-driven administration is performed during and after exposure to HIV.

[0035] In certain embodiments, the methods disclosed herein involve administration, for example, as pre-exposure prophylaxis (PrEP) and / or post-exposure prophylaxis (PEP), before and / or after an event in which the subject is exposed to HIV or otherwise increases the subject's risk of HIV infection. Examples of events that may increase the subject's risk of HIV infection include, but are not limited to, not using a condom during anal sex with an HIV-positive partner or a partner whose HIV status is unknown; having anal sex with four or more sexual partners; exchanging money, gifts, lodging, or drugs for anal sex; having sex with a male partner and being diagnosed with a sexually transmitted infection; and not consistently using a condom with a sexual partner who is known to be HIV-positive. In some embodiments, the methods disclosed herein include pre-exposure prophylaxis (PrEP). In some embodiments, the methods disclosed herein include post-exposure prophylaxis (PEP). In some embodiments, the methods disclosed herein include both pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP).

[0036] In some embodiments, a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered before the subject's exposure to HIV.

[0037] In some embodiments, a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered during the subject's exposure to HIV.

[0038] In some embodiments, a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered after the subject's exposure to HIV.

[0039] In some embodiments, a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered before and during exposure to HIV in the subject.

[0040] In some embodiments, a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered before and after exposure to HIV in the subject.

[0041] In some embodiments, a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered during and after exposure to HIV in the subject.

[0042] In some embodiments, a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered before, during, and after exposure to HIV in the subject.

[0043] In some embodiments, the doses of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, administered during each period (i.e., pre-exposure, during exposure, and post-exposure) may differ, i.e., they may be independently selected from any doses disclosed herein.

[0044] An example of an event-driven dosing regimen includes administering a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, within 5 to 10 days (e.g., about 7 days or 1 week) prior to HIV exposure (e.g., the first sexual act (including intercourse) with a sexual partner known to be HIV-positive), followed by administration of a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, once every 1 to 12 weeks during the exposure period (e.g., sexual acts with a sexual partner known to be HIV-positive). Following such a dosing regimen, a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, may be further administered after the last exposure (e.g., sexual acts with a sexual partner known to be HIV-positive).

[0045] In certain embodiments, for example, when administered as PrEP, a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered between 1 hour and 240 hours (i.e., within 10 days), 1 hour and 216 hours, 1 hour and 192 hours, 1 hour and 168 hours, 1 hour and 144 hours, 1 hour and 120 hours, 1 hour and 96 hours, 1 hour and 72 hours, 1 hour and 48 hours, 1 hour and 24 hours, or 1 hour and 12 hours before an event that increases the risk of HIV infection in the subject (e.g., before sexual intercourse or exposure to other HIV). In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered within 14, 13, 12, 11, 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 day prior to an event that increases the risk of HIV infection in the subject (e.g., sexual intercourse or exposure to another HIV). In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered within 72, 60, 48, 24, 12, 9, 6, 4, 3, 2, or 1 hour prior to an event that increases the risk of HIV infection in the subject (e.g., sexual intercourse or exposure to another HIV). In certain embodiments, when the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered prior to an event that increases the risk of HIV infection in the subject, it is administered once daily prior to the event (e.g., sexual intercourse). In a particular embodiment, formula (Ia) or If the compound of formula (Ib), or a pharmaceutically acceptable salt thereof, is administered before an event that increases the risk of HIV infection in the subject, it is administered 1 to 3 times prior to the event. In certain embodiments, if the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered before an event that increases the risk of HIV infection in the subject, it is administered once (i.e., once) prior to the event.

[0046] In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered approximately 14 days to approximately 1 day before the subject's exposure to HIV. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once approximately 14 days to approximately 1 day before the subject's exposure to HIV.

[0047] In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered approximately 10 to 5 days before the subject's exposure to HIV. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once approximately 10 to 5 days before the subject's exposure to HIV.

[0048] In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered approximately 8 to 6 days before the subject's exposure to HIV. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once approximately 8 to 6 days before the subject's exposure to HIV.

[0049] In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered approximately 7 days before the subject's exposure to HIV. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once approximately 7 days before the subject's exposure to HIV.

[0050] In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered approximately 72 hours to approximately 1 hour before the subject's exposure to HIV. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once approximately 72 hours to approximately 1 hour before the subject's exposure to HIV.

[0051] In some embodiments of the methods provided herein, pre-exposure prophylaxis (PrEP) includes sequential PrEP. In some embodiments, sequential PrEP includes administering a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, once daily about 14 days to about 1 hour before exposure to the HIV of the subject.

[0052] In certain embodiments in which a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered before exposure to the HIV in question, the method disclosed herein further comprises administering one or more additional doses of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, during and / or after exposure to the HIV in question.

[0053] In some embodiments, for example, when administered as part of a PrEP regimen or a PEP regimen, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered during the period of exposure to HIV in the subject. In specific embodiments where the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered before HIV exposure, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered approximately once every 7 days, approximately once every 14 days, approximately once every 21 days, approximately once every 28 days, approximately once every 35 days, or approximately once every 42 days (for example, as a single dose) during HIV exposure (e.g., during sexual activity with a sexual partner known to be HIV-positive). In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered to the HIV in the subject. During the exposure period, the drug is administered approximately once every 7 days, 14 days, 21 days, 28 days, 35 days, or 42 days.

[0054] In some embodiments, a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once after the last exposure to HIV (e.g., after a period of sexual intercourse with a sexual partner known to be HIV-positive) (e.g., about 7, 14, 21, or 28 days).

[0055] In some embodiments, the dosage of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, administered before exposure to HIV is different from the dosage of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, administered during and / or after exposure to HIV. For example, in some embodiments, the dosage of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is increased compared to the previous dosage (e.g., the dosage before exposure to HIV), for example, by twice the dosage, three times the dosage, and so on. In some embodiments, the increased dosage of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is twice the dosage. In some embodiments, the dosage of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is reduced compared to the previous dosage (e.g., the dosage before exposure to HIV), for example, by half the dosage.

[0056] In some embodiments, a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered as a single dose approximately 1 hour to 10 days before the subject's exposure to HIV.

[0057] Examples of additional PrEP and / or PEP can be found, for example, in the clinical trial abstracts entitled “On Demand Antiretroviral Pre-exposure Prophylaxis for HIV Infection in Men Who Have Sex With Men” (clinical trial number NCT01473472), “Prevention of HIV in Ile-de-France” (clinical trial number NCT03113123), and in Molina et al., N.Engl.J.Med.2015,353:2237-2246, each of which disclosures are incorporated herein by reference in their entirety.

[0058] In some embodiments, for example, when administered as part of a PrEP regimen or a PEP regimen, a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered between 1 hour and 10 days, 1 hour and 7 days, 1 hour and 5 days, 1 to 72 hours, 1 to 48 hours, 1 to 36 hours, 1 to 24 hours, or 1 to 12 hours following an event that increases the risk of HIV infection in the subject (e.g., following sexual intercourse or exposure to other HIV).

[0059] In certain embodiments, for example, when administered as a PEP, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered for 7, 14, 21, 28, 30, or 45 days following an event that increases the risk of HIV infection in the subject (e.g., following sexual intercourse or exposure to another HIV). In certain embodiments, for example, when administered as a PEP, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered for 30 days following an event that increases the risk of HIV infection in the subject (e.g., following sexual intercourse or exposure to another HIV). In certain embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered within 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, or 7 hours following an event that increases the risk of HIV infection in the subject (e.g., following sexual intercourse or exposure to another HIV virus). The drug is administered within 1, 8, 9, 12, 18, 24, 36, or 48 hours. In certain embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered for 1, 2, 3, 4, or 5 days following an event that increases the risk of HIV infection in the subject (e.g., following sexual intercourse or other exposure to HIV). In certain embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily following an event that increases the risk of HIV infection in the subject. In certain embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered 1 to 3 times following an event that increases the risk of HIV infection in the subject. In certain embodiments, if a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered following an event that increases the risk of HIV infection in the subject, it is administered once following the event.

[0060] In certain embodiments, for example, when administered as a PEP, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered approximately once a month, approximately once every two months, approximately once every three months, approximately once every four months, approximately once every five months, approximately once every six months, or approximately once every twelve months, following an event that increases the subject's risk of HIV infection (e.g., following sexual intercourse or exposure to another HIV). In certain embodiments, for example, when administered as a PEP, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered approximately once a month, following an event that increases the subject's risk of HIV infection (e.g., following sexual intercourse or exposure to another HIV). In certain embodiments, for example, when administered as a PEP, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered approximately once every two months, following an event that increases the subject's risk of HIV infection (e.g., following sexual intercourse or exposure to another HIV). In certain embodiments, for example, when administered as a PEP, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered approximately once every three months following an event that increases the subject's risk of HIV infection (e.g., following sexual intercourse or exposure to another HIV). In certain embodiments, for example, when administered as a PEP, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered approximately once every four months following an event that increases the subject's risk of HIV infection (e.g., following sexual intercourse or exposure to another HIV). In certain embodiments, for example, when administered as a PEP, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered approximately once every five months following an event that increases the subject's risk of HIV infection (e.g., following sexual intercourse or exposure to another HIV). In certain embodiments, for example, when administered as a PEP, a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered approximately once every six months following an event that increases the risk of HIV infection in the subject (e.g., following sexual intercourse or other exposure to HIV).In certain embodiments, for example, when administered as a PEP, a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered approximately once every 12 months following an event that increases the risk of HIV infection in the subject (e.g., following sexual intercourse or other exposure to HIV).

[0061] In certain embodiments, for example, when administered as a PEP, a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered for 1, 2, 3, 4, 5, 6, or 12 months following an event that increases the risk of HIV infection in the subject (e.g., following sexual intercourse or other exposure to HIV).

[0062] In certain embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered 1 to 50 times following an event that increases the risk of HIV infection in the subject. In certain embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered 1 to 40 times following an event that increases the risk of HIV infection in the subject. In certain embodiments If administered following an event that increases the risk of HIV infection in the subject, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered 1 to 30 times following the event. In certain embodiments, if administered following an event that increases the risk of HIV infection in the subject, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered 1 to 20 times following the event. In certain embodiments, if administered following an event that increases the risk of HIV infection in the subject, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered 1 to 15 times following the event. In certain embodiments, if administered following an event that increases the risk of HIV infection in the subject, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered 1 to 10 times following the event. In certain embodiments, if a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered following an event that increases the risk of HIV infection in the subject, it is administered 1 to 5 times following the event.

[0063] In certain embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered twice following an event that increases the risk of HIV infection in the subject. In certain embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered three times following an event that increases the risk of HIV infection in the subject. In certain embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered four times following an event that increases the risk of HIV infection in the subject. In certain embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered five times following an event that increases the risk of HIV infection in the subject. In certain embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered six times following an event that increases the risk of HIV infection in the subject. In certain embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered seven times following an event that increases the risk of HIV infection in the subject. In certain embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered eight times following an event that increases the risk of HIV infection in the subject. In certain embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered nine times following an event that increases the risk of HIV infection in the subject. In certain embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered ten times following an event that increases the risk of HIV infection in the subject.

[0064] In certain embodiments, if a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered following an event that increases the risk of HIV infection in the subject, it is administered twice following the event.

[0065] In some embodiments, a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered during the subject's exposure to HIV (for example, during sexual activity with a sexual partner known to be HIV-positive).

[0066] In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered after exposure to HIV in the subject (e.g., after the last exposure) (e.g., after a period of sexual activity with a sexual partner known to be HIV-positive). In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered between approximately 1 hour and 14 days after exposure to HIV in the subject (e.g., after the last exposure). In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered between approximately 1 hour and 14 days after exposure to HIV in the subject (e.g., after the last exposure). It is administered once during this period. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered between approximately 1 hour and 7 days after exposure to HIV in the subject (e.g., after the last exposure). In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once between approximately 1 hour and 7 days after exposure to HIV in the subject (e.g., after the last exposure). In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered between approximately 1 hour and 72 hours after exposure to HIV in the subject (e.g., after the last exposure). In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once between approximately 1 hour and 72 hours after exposure to HIV in the subject (e.g., after the last exposure). In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered between approximately 1 hour and 24 hours after exposure to HIV in the subject (e.g., after the last exposure). In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once between approximately 1 hour and 24 hours after exposure to HIV in the subject (e.g., after the last exposure). In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered between approximately 24 hours and 72 hours after exposure to HIV in the subject (e.g., after the last exposure). In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once between approximately 24 hours and 72 hours after exposure to HIV in the subject (e.g., after the last exposure).

[0067] In some embodiments, for example when administered as PrEP, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered before (e.g., before sexual activity) and after an event that increases the subject's risk of HIV infection. For example, in certain embodiments, when administered as PrEP, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered 1 to 240 hours (i.e., within 10 days), 1 to 216 hours, 1 to 192 hours, 1 to 168 hours, 1 to 144 hours, 1 to 120 hours, 1 to 96 hours, and 1 to 7 hours before an event that increases the subject's risk of HIV infection (e.g., before sexual activity). The drug is administered between 2 hours, 1 to 48 hours, 1 to 24 hours, or 1 to 12 hours after the event, and between 1 to 240 hours (i.e., within 10 days), 1 to 216 hours, 1 to 192 hours, 1 to 168 hours, 1 to 144 hours, 1 to 120 hours, 1 to 96 hours, 1 to 72 hours, 1 to 48 hours, 1 to 36 hours, 1 to 24 hours, or 1 to 12 hours after the event. For example, in some embodiments, a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once or twice (e.g., 1, 2, or 3 times) between 1 to 10 days (e.g., 7 days) before an event that increases the risk of HIV infection in the subject, and once during the period of 1 to 10 days after the event. In some embodiments, a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once, twice, three, four, or five times a week, starting 1 to 48 hours apart, in one or more doses (e.g., one, two, or three times), following an event that increases the risk of HIV infection in the subject (e.g., following sexual intercourse).

[0068] In some embodiments, the method is (i) Administering a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, approximately 7 days before the subject's exposure to HIV, (ii) During the period of exposure to HIV, administer a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, once every seven days. In some embodiments, the dosage of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof administered in step (i) is different from the dosage of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof administered in step (ii).

[0069] In some embodiments, the method is (i) Administering a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, approximately 7 days before the subject's exposure to HIV, (ii) During the period of exposure to HIV, administer a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, once every 14 days. In some embodiments, the dosage of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof administered in step (i) is different from the dosage of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof administered in step (ii).

[0070] In some embodiments, the method is (i) Administering a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, approximately 7 days before the subject's exposure to HIV, (ii) During the period of exposure to HIV, administer a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, once every 21 days. In some embodiments, the dosage of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof administered in step (i) is different from the dosage of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof administered in step (ii).

[0071] In some embodiments, the method is (i) Administering a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, approximately 7 days before the subject's exposure to HIV, (ii) During the period of exposure to HIV, administer a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, once every 28 days. In some embodiments, the dosage of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof administered in step (i) is different from the dosage of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof administered in step (ii).

[0072] In some embodiments, the method is (i) Administering a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, approximately 7 days before the subject's exposure to HIV, (ii) During the period of exposure to HIV, administer a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, once every 35 days. In some embodiments, the dosage of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof administered in step (i) is different from the dosage of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof administered in step (ii).

[0073] In some embodiments, the method is (i) Administering a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, approximately 7 days before the subject's exposure to HIV, (ii) During the period of exposure to HIV, administer a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, once every 42 days. In some embodiments, the dosage of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof administered in step (i) is different from the dosage of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof administered in step (ii).

[0074] In some embodiments, the method is (i) Administering a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, approximately 7 days before the subject's exposure to HIV, (ii) During the period of exposure to HIV, administer a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, once a month.

[0075] In some embodiments, the method is (i) Administering a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, approximately 7 days before the subject's exposure to HIV, (ii) During the period of exposure to HIV, administer a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, once every two months.

[0076] In some embodiments, the method is (i) Administering a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, approximately 7 days before the subject's exposure to HIV, (ii) During the period of exposure to HIV, administer a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, once every three months.

[0077] In some embodiments, the method is (i) Administering a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, approximately 7 days before the subject's exposure to HIV, (ii) During the period of exposure to HIV, administer a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, once every six months.

[0078] In some embodiments, the method is (i) Administering a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, approximately 7 days before the subject's exposure to HIV, (ii) During the period of exposure to HIV, administer a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, once every 12 months.

[0079] In some embodiments, the method is (i) Administering a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, approximately 7 days before the subject's exposure to HIV, (ii) During the period of exposure to HIV, administer a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, once a month. In some embodiments, the dosage of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof administered in step (i) is different from the dosage of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof administered in step (ii).

[0080] In some embodiments, the method is (i) Administering a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, approximately 7 days before the subject's exposure to HIV, (ii) During the period of exposure to HIV, administer a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, once every two months. In some embodiments, the dosage of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof administered in step (i) is different from the dosage of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof administered in step (ii).

[0081] In some embodiments, the method is (i) Administering a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, approximately 7 days before the subject's exposure to HIV, (ii) During the period of exposure to HIV, administer a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, once every three months. In some embodiments, the dosage of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof administered in step (i) is different from the dosage of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof administered in step (ii).

[0082] In some embodiments, the method is (i) Administering a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, approximately 7 days before the subject's exposure to HIV, (ii) During the period of exposure to HIV, administer a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, once every six months. In some embodiments, the dosage of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof administered in step (i) is different from the dosage of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof administered in step (ii).

[0083] In some embodiments, the method is (i) Administering a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, approximately 7 days before the subject's exposure to HIV, (ii) During the period of exposure to HIV, administer a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, once every 12 months. In some embodiments, the dosage of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof administered in step (i) is different from the dosage of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof administered in step (ii).

[0084] In some embodiments, the administration of a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof (as in step (i) or (ii)) (a) Bictegravir, or a pharmaceutically acceptable salt thereof (b) Tenofovir alafenamide, or a pharmaceutically acceptable salt thereof, (c) Further comprising administration of bictegravir or a pharmaceutically acceptable salt thereof and tenofovir alafenamide or a pharmaceutically acceptable salt thereof.

[0085] In some embodiments, the administration of a compound of formula (Ia) or formula (Ib) or a pharmaceutically acceptable salt thereof (as in step (i) or (ii)) further comprises the administration of bictegravir or a pharmaceutically acceptable salt thereof in doses of about 10 mg to about 600 mg, and tenofovir alafenamide or a pharmaceutically acceptable salt thereof in doses of about 10 mg to about 50 mg.

[0086] In some embodiments, the administration of a compound of formula (Ia) or formula (Ib) or a pharmaceutically acceptable salt thereof (as in step (i) or (ii)) further comprises the administration of bictegravir or a pharmaceutically acceptable salt thereof in doses of about 10 mg to about 200 mg, and tenofovir alafenamide or a pharmaceutically acceptable salt thereof in doses of about 10 mg to about 50 mg.

[0087] Furthermore, this specification provides a method for reducing the risk of HIV infection in a subject, comprising administering a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, to the subject.

[0088] In some embodiments, a method for reducing the risk of HIV (e.g., HIV-1 and / or HIV-2) infection includes administering a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, to a subject in combination with safer sexual practices. In certain embodiments, a method for reducing the risk of HIV (e.g., HIV-1 and / or HIV-2) infection includes administering a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, to a subject at risk of HIV infection. Examples of subjects at high risk of HIV infection include, but are not limited to, subjects at risk of sexual transmission of HIV.

[0089] In some embodiments, the reduction in HIV infection risk is at least about 40%, 50%, 60%, 70%, 80%, 90%, or 95% (compared to a subject not administered with a compound of formula (Ia) or formula (Ib) or a pharmaceutically acceptable salt thereof by any of the methods provided herein). In some embodiments, the reduction in HIV infection risk is about 80%, 85%, or 90%. In some embodiments, the reduction in HIV infection risk is at least about 75%. In some embodiments, the reduction in HIV infection risk is at least about 80%. In some embodiments, the reduction in HIV infection risk is at least about 85%. In some embodiments, the reduction in HIV infection risk is at least about 90%. Administration regimen

[0090] In some embodiments, a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered to a subject (e.g., a human patient) for a desired period or duration according to an effective administration regimen. In some embodiments, the administration regimen includes administering a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, for at least about 1 week, about 2 weeks, about 4 weeks, about 8 weeks, about 12 weeks, about 16 weeks, about 20 weeks, about 24 weeks, about 28 weeks, about 32 weeks, about 36 weeks, about 40 weeks, about 44 weeks, about 48 weeks, about 52 weeks, or longer.

[0091] In some embodiments, the administration regimen includes administering a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, for at least about one, two, three, four, five, ten, or longer period. In some embodiments, the administration regimen includes administering a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, continuously for the lifetime of the subject.

[0092] In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily or on an intermittent schedule. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered on a monthly schedule. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered approximately once a week, approximately once every two weeks, approximately once every four weeks, approximately once every eight weeks, approximately once every twelve weeks, approximately once every sixteen weeks, approximately once every twenty weeks, approximately once every twenty-four weeks, or approximately once every forty-eight weeks. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once every four weeks (or one month). In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once every eight weeks (or two months). In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once every twelve weeks (or three months). In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once every sixteen weeks (or four months). In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once every twenty weeks (or five months). In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once every twenty-four weeks (or six months). In some embodiments, a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once every 52 weeks (or year).

[0093] In some embodiments, a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered approximately once a month, approximately once every two months, approximately once every three months, approximately once every four months, approximately once every five months, approximately once every six months, or approximately once every twelve months during the period of exposure to HIV in question. In some embodiments, a compound of formula (Ia) or formula (Ib), or The pharmaceutically acceptable salt is administered approximately once a month during the period of exposure to HIV. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered approximately once every two months during the period of exposure to HIV. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered approximately once every three months during the period of exposure to HIV. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered approximately once every four months during the period of exposure to HIV. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered approximately once every five months during the period of exposure to HIV. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered approximately once every six months during the period of exposure to HIV. In some embodiments, a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered approximately once every 12 months during the subject's HIV exposure period.

[0094] In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered subcutaneously to a subject (e.g., a human patient) for at least about one month. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered subcutaneously or intramuscularly to a subject for at least about two months, at least about three months, at least about four months, or at least about six months. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered subcutaneously to a subject about once a month. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered subcutaneously or intramuscularly to a subject about once every three months. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered subcutaneously or intramuscularly to a subject about once every six months.

[0095] In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered to the subject subcutaneously or intramuscularly approximately once every 12 months. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered to the subject subcutaneously approximately once every 12 months. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered to the subject intramuscularly approximately once every 12 months.

[0096] In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered intramuscularly to the subject approximately once a month. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered subcutaneously to the subject approximately once every three months. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered intramuscularly to the subject approximately once every three months. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered subcutaneously to the subject approximately once every six months. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered intramuscularly to the subject approximately once every six months. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered subcutaneously to the subject approximately once a year. In some embodiments, a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered intramuscularly to a subject approximately once a year.

[0097] In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered orally to the subject once daily. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered to the subject approximately once a week, approximately once every two weeks, approximately once every four weeks, approximately once every eight weeks, approximately once every twelve weeks, approximately once every sixteen weeks, approximately once every twenty weeks, approximately once every twenty-four weeks, approximately once every forty-eight weeks, or approximately once every year. It is administered orally. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered orally to the subject about once a week. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered orally to the subject about once a month. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered orally to the subject about once every three months. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered orally to the subject about once every six months. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered orally to the subject about once a year.

[0098] The dosage or frequency of administration of the compound of formula (Ia) or formula (Ib) or its pharmaceutically acceptable salt may be adjusted throughout the course of treatment at the discretion of the administering physician.

[0099] In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered to a subject (e.g., a human) in a therapeutically effective dose. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once a month. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once every two months. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once every three months. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once every four months. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once every six months. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once a year.

[0100] In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered in an effective dose. In some embodiments, the dose is about 1 mg to about 1000 mg of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof. In certain embodiments, the dose is about 1 mg, about 10 mg, about 20 mg, about 30 mg, about 40 mg, about 50 mg, about 60 mg, about 70 mg, about 80 mg, about 90 mg, about 95 mg, about 100 mg, about 105 mg, about 110 mg, about 120 mg, about 130 mg, about 140 mg, or about 150 mg of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof. In certain embodiments, the dosage is about 100 mg, about 150 mg, about 200 mg, about 250 mg, about 300 mg, about 350 mg, about 400 mg, about 450 mg, about 500 mg, about 550 mg, about 600 mg, about 650 mg, about 700 mg, about 750 mg, about 800 mg, about 850 mg, about 900 mg, about 950 mg, or about 1000 mg of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof.

[0101] In certain embodiments, the dosage is approximately 1 mg, 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg, 80 mg, 90 mg, 100 mg, 110 mg, 120 mg, 130 mg, 140 mg, 150 mg, and 200 mg of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof. mg, about 250mg, about 300mg, about 350mg, about 400mg, about 450mg, about 500mg, about 550mg, about 600mg, about 650mg, about 700mg, about 750mg, Approximately 800mg, approximately 850mg, approximately 900mg, approximately 950mg, approximately 1000mg, approximately 1050mg, approximately 1100mg, approximately 1150mg, approximately 1200mg, approximately 1250mg, approximately 130 The available doses are 0 mg, approximately 1350 mg, approximately 1400 mg, approximately 1450 mg, approximately 1500 mg, approximately 1550 mg, approximately 2000 mg, approximately 2050 mg, and approximately 3000 mg.

[0102] In some embodiments, the dosage of the compound of formula (Ia) or formula (Ib), or its pharmaceutically acceptable salt, is about 1 mg to about 2500 mg. In some embodiments, the dosage of the compound of formula (Ia) or formula (Ib), or its pharmaceutically acceptable salt, is about 5 mg to about 2400 mg. In some embodiments, the dosage of the compound of formula (Ia) or formula (Ib), or its pharmaceutically acceptable salt, is about 5 mg to about 2000 mg. In some embodiments, the dosage of the compound of formula (Ia) or formula (Ib), or its pharmaceutically acceptable salt, is about 5 mg to about 1500 mg. In some embodiments, the dosage of the compound of formula (Ia) or formula (Ib), or its pharmaceutically acceptable salt, is about 5 mg to about 1200 mg. In some embodiments, the dosage of the compound of formula (Ia) or formula (Ib), or its pharmaceutically acceptable salt, is about 5 mg to about 1000 mg. In some embodiments, the dosage of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is about 5 mg to about 500 mg. In some embodiments, the dosage of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is about 5 mg to about 300 mg. In some embodiments, the dosage of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is about 5 mg to about 200 mg. In some embodiments, the dosage of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is about 5 mg to about 100 mg. In some embodiments, the dosage of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is about 5 mg to about 50 mg.

[0103] In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of approximately 1 mg to approximately 1500 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of approximately 5 mg to approximately 1200 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of approximately 100 mg to approximately 1200 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of approximately 200 mg to approximately 1200 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of approximately 300 mg to approximately 1200 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily in a dose of approximately 500 mg to approximately 1200 mg.

[0104] In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of about 1 mg to about 200 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of about 5 mg to about 200 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of about 10 mg to about 200 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of about 50 mg to about 200 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of about 100 mg to about 200 mg.

[0105] In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is approximately 1 mg, approximately 5 mg, approximately 10 mg, approximately 15 mg, approximately 20 mg, approximately 25 mg, approximately 30 mg, approximately 35 mg, approximately 40 mg, approximately 45 mg, approximately 50 mg, approximately 55 mg, and approximately 6 mg. 0mg, about 65mg, about 70mg, about 75mg, about 80mg, about 85mg, about 90mg, about 95mg, about 100mg, about 105mg, about 110mg, about 115mg, about 120mg, about 125mg, about 130mg, about 135m g, approx. 140 mg, approx. 145 mg, approx. 150 mg, approx. 155 mg, approx. 160 mg, approx. 165 mg, approx. 170 mg, approx. 175 mg, approx. 180 mg, approx. It is administered once daily in doses of 300 mg, approximately 350 mg, approximately 400 mg, approximately 450 mg, approximately 500 mg, approximately 550 mg, approximately 600 mg, approximately 650 mg, approximately 700 mg, approximately 750 mg, approximately 800 mg, approximately 850 mg, approximately 900 mg, approximately 950 mg, approximately 1000 mg, approximately 1050 mg, approximately 1100 mg, approximately 1150 mg, approximately 1200 mg, approximately 1250 mg, approximately 1300 mg, approximately 1350 mg, approximately 1400 mg, approximately 1450 mg, or approximately 1500 mg.

[0106] In some embodiments, a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of approximately 1 mg.

[0107] In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of approximately 5 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of approximately 10 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of approximately 15 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of approximately 20 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of approximately 25 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of approximately 50 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of approximately 75 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of approximately 100 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of approximately 125 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of approximately 150 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of approximately 175 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of approximately 200 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of approximately 300 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of approximately 400 mg.In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of approximately 500 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of approximately 600 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of approximately 700 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of approximately 800 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of approximately 900 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of approximately 1000 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of approximately 1100 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of approximately 1200 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of approximately 1300 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of approximately 1400 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of approximately 1500 mg.

[0108] In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 100 mg to approximately 2500 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 100 mg to approximately 2400 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 100 mg to approximately 2000 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 300 mg to approximately 2500 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 500 mg to approximately 2500 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 800 mg to approximately 2500 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 1000 mg to approximately 2500 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 100 mg to approximately 1200 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 150 mg to approximately 1200 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 200 mg to approximately 1200 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 300 mg to approximately 1200 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 500 mg to approximately 1200 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 600 mg to approximately 1200 mg.In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 800 mg to approximately 1200 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 1000 mg to approximately 1200 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is present in amounts of approximately 100 mg, approximately 125 mg, approximately 150 mg, approximately 175 mg, approximately 200 mg, approximately 225 mg, approximately 250 mg, approximately 275 mg, approximately 300 mg, approximately 325 mg, approximately 350 mg, approximately 375 mg, approximately 400 mg, approximately 425 mg, approximately 450 mg, approximately 475 mg, approximately 500 mg, approximately 525 mg, approximately 550 mg, approximately 575 mg, approximately 600 mg, approximately 625 mg, approximately 650 mg, approximately 675 mg, approximately 700 mg, approximately 725 mg, approximately 750 mg, approximately 775 mg, approximately 800 mg, approximately 825 mg , about 850mg, about 875mg, about 900mg, about 925mg, about 950mg, about 975mg, about 1000mg, about 1025mg, about 1050mg, about 1075mg, about 1100mg, about 1125mg, about 1150mg, about 1175mg, about 1200mg, about 1250mg, about 1300 mg, about 1350mg, about 1400mg, about 1450mg, about 1500mg, about 1550mg, about 1600mg, about 1650mg, about 1700mg, about 1750mg, about 1800mg, about 1850mg, about 1900mg, about 1950mg, about 2000mg, about 2050mg, about 2100. It is administered once a week in doses of approximately mg, 2150 mg, 2200 mg, 2250 mg, 2300 mg, 2350 mg, 2400 mg, 2450 mg, or 2500 mg.

[0109] In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 100 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 150 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 175 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 200 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 300 mg.

[0110] In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 400 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 500 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 600 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 700 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 800 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 900 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 1000 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 1100 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 1200 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 1300 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 1400 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 1500 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 1600 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 1700 mg.In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 1800 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 1900 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 2000 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 2100 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 2200 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 2300 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 2400 mg. In some embodiments, formula (Ia). Alternatively, the compound of formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once weekly at a dose of approximately 2500 mg.

[0111] In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once a month at a dose of about 100 mg to about 3000 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once a month at a dose of about 100 mg to about 2500 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once a month at a dose of about 100 mg to about 2400 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once a month at a dose of about 100 mg to about 2000 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once a month at a dose of approximately 300 mg to approximately 2500 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once a month at a dose of approximately 500 mg to approximately 2500 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once a month at a dose of approximately 800 mg to approximately 2500 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once a month at a dose of approximately 1000 mg to approximately 2500 mg.

[0112] In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once a month at a dose of approximately 200 mg to approximately 2000 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once a month at a dose of approximately 300 mg to approximately 2000 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once a month at a dose of approximately 400 mg to approximately 2000 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once a month at a dose of approximately 500 mg to approximately 2000 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once a month at a dose of approximately 800 mg to approximately 2000 mg. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered once a month at a dose of approximately 1000 mg to approximately 2000 mg.In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is present in amounts of approximately 100 mg, approximately 125 mg, approximately 150 mg, approximately 175 mg, approximately 200 mg, approximately 225 mg, approximately 250 mg, approximately 275 mg, approximately 300 mg, approximately 325 mg, approximately 350 mg, approximately 375 mg, approximately 400 mg, approximately 425 mg, approximately 450 mg, approximately 475 mg, approximately 500 mg, and approximately 52 mg. 5mg, about 550mg, about 575mg, about 600mg, about 625mg, about 650mg, about 675mg, about 700mg, about 725mg, about 750mg, about 775mg, about 800mg, about 82 5mg, about 850mg, about 875mg, about 900mg, about 925mg, about 950mg, about 975mg, about 1000mg, about 1025mg, about 1050mg, about 1075mg, about 1100mg , about 1125mg, about 1150mg, about 1175mg, about 1200mg, about 1250mg, about 1300mg, about 1350mg, about 1400mg, about 1450mg, about 1500mg, about 15 50mg, about 1600mg, about 1650mg, about 1700mg, about 1750mg, about 1800mg, about 1850mg, about 1900mg, about 1950mg, about 2000mg, about 2050mg, It is administered once a month in doses of approximately 2100 mg, 2150 mg, 2200 mg, 2250 mg, 2300 mg, 2350 mg, 2400 mg, 2450 mg, 2500 mg, 2550 mg, 2600 mg, 2650 mg, 2700 mg, 2750 mg, 2800 mg, 2850 mg, 2900 mg, 2950 mg, or 3000 mg.

[0113] In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered at a dose of approximately 100 mg once a month. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered at a dose of approximately 150 mg once a month. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered at a dose of approximately 200 mg once a month. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered at a dose of approximately 300 mg once a month. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered at a dose of approximately 400 mg once a month. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered at a dose of approximately 500 mg once a month. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered at a dose of approximately 800 mg once a month. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered at a dose of approximately 1000 mg once a month. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered at a dose of approximately 1100 mg once a month. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered at a dose of approximately 1200 mg once a month. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered at a dose of approximately 1500 mg once a month. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered at a dose of approximately 1800 mg once a month. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered at a dose of approximately 2000 mg once a month. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered at a dose of approximately 2100 mg once a month.In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered at a dose of approximately 2200 mg once a month. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered at a dose of approximately 2300 mg once a month. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered at a dose of approximately 2400 mg once a month. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered at a dose of approximately 2500 mg once a month. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered at a dose of approximately 2600 mg once a month. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered at a dose of approximately 2700 mg once a month. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered at a dose of approximately 2800 mg once a month. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered at a dose of approximately 2900 mg once a month. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered at a dose of approximately 3000 mg once a month.

[0114] In some embodiments, a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered at a dose of approximately 600 mg once every six months. Salts and compositions

[0115] This method involves administering a salt of the compound of formula (Ia) or formula (Ib), for example, a pharmaceutically acceptable salt. A salt is generally a derivative of the disclosed compound, in which the parent compound is modified by converting an existing acid or base portion into a salt form. A pharmaceutically acceptable salt is one that, within the bounds of sound medical judgment, does not cause excessive toxicity, irritation, allergic reactions, etc. A pharmaceutically acceptable salt is a salt suitable for use in contact with human and animal tissues, with a reasonable benefit-to-risk ratio, without other problems or complications. Examples of pharmaceutically acceptable salts include, but are not limited to, inorganic or organic acid salts of basic residues such as amines; alkali or organic salts of acidic residues such as carboxylic acids; and others. The pharmaceutically acceptable salts of this disclosure include, for example, conventional non-toxic salts of parent compounds formed from non-toxic inorganic or organic acids. The pharmaceutically acceptable salts of this disclosure can be synthesized from parent compounds containing basic or acidic moieties by conventional chemical methods. Generally, such salts can be prepared by reacting the free acidic or basic form of these compounds with a stoichiometric amount of a suitable base or acid. A list of suitable salts can be found in Remington's Pharmaceutical Sciences, 17th ed., Mack Publishing Company, Easton, Pa., 1985, p. 1418 and Journal of Pharmaceutical Science, 66, 2 (1977), each of which is incorporated herein by reference in its entirety. In some embodiments, the salt is a sodium salt.

[0116] A compound of formula (Ia) or formula (Ib) or a salt thereof may be present in a composition (such as a pharmaceutical composition or preparation) in which the composition contains at least one compound other than a compound of formula (Ia) or formula (Ib) or a salt thereof as disclosed herein.

[0117] In some embodiments, the composition comprises a compound of formula (Ia) or formula (Ib), or a salt thereof, and one or more additional compounds (e.g., one or more additional therapeutic compounds), or a salt thereof. In some embodiments, the composition comprises a compound of formula (Ia) or formula (Ib), or a salt thereof; bictegravir, or a salt thereof; and one or more additional compounds (e.g., one or more additional therapeutic compounds such as tenofovir alafenamide, or a pharmaceutically acceptable salt thereof), or a salt thereof.

[0118] The composition may comprise a compound of formula (Ia) or formula (Ib), or a salt thereof, and a mixture comprising one or more solvents, substrates, carriers, etc. In some embodiments, the composition comprises more than about 25% by weight of a compound of formula (Ia) or formula (Ib), or a salt thereof, for example, more than about 25% by weight, more than about 50% by weight, more than about 75% by weight, more than about 80% by weight, more than about 90% by weight, or more than about 95% by weight.

[0119] This disclosure further includes pharmaceutical compositions comprising a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, and at least one pharmaceutically acceptable carrier. As used herein, “pharmaceutically acceptable carrier” means any adjuvant, carrier, excipient, flow enhancer, sweetener, diluent, preservative, dye / colorant, flavor enhancer, surfactant, wetting agent, dispersant, suspending agent, stabilizer, isotonic agent, solvent, or emulsifier approved by the U.S. Food and Drug Administration as acceptable for use in humans or livestock.

[0120] The administration of a compound of formula (Ia) or formula (Ib) or a pharmaceutically acceptable salt thereof may be carried out via any of the accepted modes of administration of a drug for similar efficacy. The pharmaceutical compositions of this disclosure can be prepared by combining a compound of formula (Ia) or formula (Ib) or a pharmaceutically acceptable salt thereof with a suitable pharmaceutically acceptable carrier, and in specific embodiments, may be formulated into solid, semi-solid, liquid, or gaseous formulations such as tablets, capsules, powders, granules, ointments, solutions, suppositories, injections, inhalants, gels, microspheres, and aerosols. Exemplary routes of administration of such pharmaceutical compositions include, but are not limited to, oral, topical, transdermal, inhalation, parenteral, sublingual, buccal, rectal, vaginal, and intranasal. In some embodiments, the pharmaceutical compositions of this disclosure are tablets. In some embodiments, the pharmaceutical compositions of this disclosure are injections (e.g., intramuscular (IM) or intraperitoneal (IP)). When the pharmaceutical composition of this disclosure is administered to a subject, the active ingredients contained herein are The formulation is made bioavailable. The composition administered to the subject takes the form of one or more dosage units; for example, a tablet may be a single dosage unit, and a container of the compound of formula (Ia) or formula (Ib) or a pharmaceutically acceptable salt thereof in aerosol form may hold multiple dosage units. Practical methods for preparing such dosage forms are known or obvious to those skilled in the art; see, for example, Remington: The Science and Practice of Pharmacy, 20th Edition (Philadelphia College of Pharmacy and Science, 2000). In any case, the administered composition contains a therapeutically effective amount of the compound of formula (Ia) or formula (Ib) or a pharmaceutically acceptable salt thereof for the prevention of HIV infection or the reduction of the risk of HIV infection, as described herein.

[0121] In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered orally, subcutaneously, intramuscularly, or intravenously.

[0122] In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered orally. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered orally at a concentration of about 20 mg / mL to about 300 mg / mL. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered orally at a concentration of about 300 mg / mL. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered orally at a concentration of about 200 mg / mL. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered orally at a concentration of about 20 mg / mL to about 100 mg / mL. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered orally at a concentration of about 30 mg / mL. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered orally at a concentration of about 50 mg / mL.

[0123] In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is formulated as a hard gelatin capsule.

[0124] In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is formulated as a soft gelatin capsule.

[0125] In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is formulated as a tablet. In some embodiments, the tablet contains about 5 mg to about 500 mg of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet contains about 50 mg of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet contains about 300 mg of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof.

[0126] In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered parenterally. Parenteral administration includes, but is not limited to, intravenous, intra-arterial, subcutaneous, intraperitoneal, intramuscular, intracranial, transdermal, and intravaginal administration. Parenteral administration can be, for example, in the form of a single bolus or by continuous perfusion pump. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered to the subject via a medical device. Exemplary medical devices include patches (e.g., transdermal patches), implantable devices (e.g., implantable devices for quantitative or sustained release of the activator; subcutaneous devices), syringes, contraceptive devices (e.g., vaginal rings, intrauterine devices), etc. This is not limited to these.

[0127] In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered subcutaneously. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered subcutaneously at a concentration of about 10 mg / mL to about 500 mg / mL. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered subcutaneously at a concentration of about 50 mg / mL. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered subcutaneously at a concentration of about 100 mg / mL. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered subcutaneously at a concentration of about 150 mg / mL. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered subcutaneously at a concentration of approximately 300 mg / mL.

[0128] In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered subcutaneously at a concentration of approximately 125 mg / mL. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered subcutaneously at a concentration of approximately 309 mg / mL. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered subcutaneously at a concentration of approximately 400 mg / mL. In some embodiments, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered subcutaneously at a concentration of approximately 500 mg / mL.

[0129] In some embodiments of the methods provided herein, the compound of formula (Ia) or formula (Ib) is administered to a target as a solution (for example, for subcutaneous administration or for example, for oral administration via capsule). In some embodiments, the solution comprises the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, PEG300, and water. In some embodiments, the solution comprises the compound of formula (Ia) or a pharmaceutically acceptable salt thereof, PEG300, and water. In some embodiments, the solution comprises the compound of formula (Ib), or a pharmaceutically acceptable salt thereof, PEG300, and water. In some embodiments, the solution comprises the sodium salt of the compound of formula (Ia), PEG300, and water. In some embodiments, the solution comprises the compound of formula (Ib), PEG300, and water.

[0130] In some embodiments, the solution comprises the compound of formula (Ia), PEG300, and water. In some embodiments, the concentration of the compound of formula (Ia) in the solution comprising the compound of formula (Ia), PEG300, and water is about 50 mg / mL to about 500 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in the solution comprising the compound of formula (Ia), PEG300, and water is about 50 mg / mL to about 400 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in the solution comprising the compound of formula (Ia), PEG300, and water is about 50 mg / mL to about 300 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in the solution comprising the compound of formula (Ia), PEG300, and water is about 75 mg / mL to about 300 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, and water is about 50 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, and water is about 75 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, and water is about 100 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, and water is about 125 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, and water is about 150 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, and water is about 150 mg / mL. The concentration is approximately 175 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, and water is approximately 200 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, and water is approximately 225 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, and water is approximately 250 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, and water is approximately 275 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, and water is approximately 300 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, and water is approximately 325 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, and water is approximately 350 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, and water is approximately 375 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, and water is approximately 400 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, and water is approximately 425 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, and water is approximately 450 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, and water is approximately 475 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, and water is approximately 500 mg / mL.

[0131] In some embodiments, the amount of water in a solution containing the compound of formula (Ia), PEG300, and water is about 5 w / w% to about 15 w / w%. In some embodiments, the amount of water in a solution containing the compound of formula (Ia), PEG300, and water is about 5 w / w% to about 10 w / w%. In some embodiments, the amount of water in a solution containing the compound of formula (Ia), PEG300, and water is about 8 w / w% to about 12 w / w%. In some embodiments, the amount of water in a solution containing the compound of formula (Ia), PEG300, and water is about 9 w / w% to about 10 w / w%. In some embodiments, the amount of water in a solution containing the compound of formula (Ia), PEG300, and water is approximately 8.0 w / w%, 8.1 w / w%, 8.2 w / w%, 8.3 w / w%, 8.4 w / w%, 8.5 w / w%, 8.6 w / w%, 8.7 w / w%, 8.8 w / w%, 8.9 w / w%, 9.0 w / w%, 9.1 w / w%, 9.2 w / w%, 9.3 w / w%, 9.4 w / w%, 9.5 w / w%, 9.6 w / w%, 9.7 w / w%, 9.8 w / w%, and 9.9 w / w%. The percentages are w / w%, approximately 10.0 w / w%, approximately 10.1 w / w%, approximately 10.2 w / w%, approximately 10.3 w / w%, approximately 10.4 w / w%, approximately 10.5 w / w%, approximately 10.6 w / w%, approximately 10.7 w / w%, approximately 10.8 w / w%, approximately 10.9 w / w%, approximately 11.0 w / w%, approximately 11.1 w / w%, approximately 11.2 w / w%, approximately 11.3 w / w%, approximately 11.4 w / w%, approximately 11.5 w / w%, approximately 11.6 w / w%, approximately 11.7 w / w%, approximately 11.8 w / w%, approximately 11.9 w / w%, or approximately 12.0 w / w%. In some embodiments, the amount of water in a solution containing the compound of formula (Ia), PEG300, and water is about 9.0 w / w%, about 9.1 w / w%, about 9.2 w / w%, about 9.3 w / w%, about 9.4 w / w%, about 9.5 w / w%, about 9.6 w / w%, about 9.7 w / w%, about 9.8 w / w%, about 9.9 w / w%, or about 10.0 w / w%. In some embodiments, the amount of water in a solution containing the compound of formula (Ia), PEG300, and water is about 9.5 w / w%, about 9.6 w / w%, about 9.7 w / w%, about 9.8 w / w%, about 9.9 w / w%, or about 10.0 w / w%. In some embodiments, the amount of water in a solution containing the compound of formula (Ia), PEG300, and water is about 9.8 w / w%.In some embodiments, the amount of water in a solution containing the compound of formula (Ia), PEG300, and water is approximately 10 w / w%.

[0132] In some embodiments, the amount of PEG300 in a solution containing the compound of formula (Ia), PEG300, and water is about 50 w / w% to about 85 w / w%. In some embodiments, the amount of PEG300 in a solution containing the compound of formula (Ia), PEG300, and water is about 60 w / w% to about 80 w / w%. In some embodiments, the amount of PEG300 in a solution containing the compound of formula (Ia), PEG300, and water is about 60 w / w% to about 70 w / w%. In some embodiments, the amount of PEG300 in a solution containing the compound of formula (Ia), PEG300, and water is about 50 w / w%, about 55 w / w%, about 60 w / w%, about 65 w / w%, about 70 w / w%, about 75 w / w%, about 80 w / w%, or about 85 w / w%. In some embodiments, the amount of PEG300 in a solution containing the compound of formula (Ia), PEG300, and water is about 65 w / w%. In some embodiments, the amount of PEG300 in a solution containing the compound of formula (Ia), PEG300, and water is about 65.0 w / w%.

[0133] In some embodiments, the amount of compound (Ia) in a solution containing the compound of formula (Ia), PEG300, and water is about 15 w / w% to about 35 w / w%. In some embodiments, the amount of compound (Ia) in a solution containing the compound of formula (Ia), PEG300, and water is about 20 w / w% to about 35 w / w%. In some embodiments, the amount of compound (Ia) in a solution containing the compound of formula (Ia), PEG300, and water is about 24 w / w% to about 26 w / w%. In some embodiments, the amount of compound (Ia) in a solution containing the compound of formula (Ia), PEG300, and water is about 24.5 w / w%, about 24.6 w / w%, about 24.7 w / w%, about 24.8 w / w%, about 24.9 w / w%, about 25.0 w / w%, about 25.1 w / w%, about 25.2 w / w%, about 25.3 w / w%, about 25.4 w / w%, or about 25.5 w / w%. In some embodiments, the amount of compound (Ia) in a solution containing the compound of formula (Ia), PEG300, and water is about 25 w / w%. In some embodiments, the amount of compound (Ia) in a solution containing the compound of formula (Ia), PEG300, and water is about 25.2 w / w%.

[0134] In some embodiments, the solution contains about 5 w / w% to about 15 w / w% water, about 50 w / w% to about 85 w / w% PEG300, and about 15 w / w% to about 35 w / w% of the compound of formula (Ia). In some embodiments, the solution contains about 5 w / w% to about 10 w / w% water, about 60 w / w% to about 80 w / w% PEG300, and about 20 w / w% to about 35 w / w% of the compound of formula (Ia). In some embodiments, the solution contains about 8 w / w% to about 12 w / w% water, about 60 w / w% to about 70 w / w% PEG300, and about 15 w / w% to about 35 w / w% of the compound of formula (Ia). In some embodiments, the solution contains about 9 w / w% to about 10 w / w% water, about 60 w / w% to about 70 w / w% PEG300, and about 24 w / w% to about 26 w / w% of the compound of formula (Ia). In some embodiments, the solution contains about 9.8 w / w% water, about 65.0 w / w% PEG300, and about 25.2 w / w% of the compound of formula (Ia). In some embodiments, the solution contains about 10 w / w% water, about 65.0 w / w% PEG300, and about 25 w / w% of the compound of formula (Ia).

[0135] In some embodiments, the solution comprises the sodium salt of the compound of formula (Ia), PEG300, and water. In some embodiments, the concentration of the compound of formula (Ia) in the solution comprising the sodium salt of the compound of formula (Ia), PEG300, and water is about 50 mg / mL to about 500 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in the solution comprising the sodium salt of the compound of formula (Ia), PEG300, and water is about 50 mg / mL to about 300 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in the solution comprising the sodium salt of the compound of formula (Ia), PEG300, and water is about 75 mg / mL to about 300 mg / mL. In some embodiments, the sodium of the compound of formula (Ia) The concentration of the compound of formula (Ia) in a solution containing the sodium salt, PEG300, and water is approximately 50 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the sodium salt, PEG300, and water is approximately 75 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the sodium salt, PEG300, and water is approximately 100 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the sodium salt, PEG300, and water is approximately 125 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the sodium salt, PEG300, and water is approximately 150 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the sodium salt, PEG300, and water is approximately 175 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 200 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 225 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 250 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 275 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 300 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is approximately 325 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is approximately 350 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is approximately 375 mg / mL.In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 400 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 425 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 450 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 475 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 500 mg / mL.

[0136] In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is approximately 309 mg / mL.

[0137] In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 10 w / w% to about 40 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 15 w / w% to about 35 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 20 w / w% to about 30 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 21 w / w% to about 29 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 23.4 w / w% to about 27.5 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 23.41 w / w% to about 27.47 w / w%. These are approximately 22.0 w / w%, 22.1 w / w%, 22.2 w / w%, 22.3 w / w%, 22.4 w / w%, 22.5 w / w%, 22.6 w / w%, 22.7 w / w%, 22.8 w / w%, 22.9 w / w%, 23.0 w / w%, 23.1 w / w%, 23.2 w / w%, 23.3 w / w%, 23.4 w / w%, 23.5 w / w%, 23.6 w / w%, and 23.7 w / w%, approximately 23.8 w / w%, approximately 23.9 w / w%, approximately 24.0 w / w%, approximately 24.1 w / w%, approximately 24.2 w / w%, approximately 24.3 w / w%, approximately 24.4 w / w%, approximately 24.5 w / w%, approximately 24.6 w / w%, approximately 24.7 w / w%, approximately 24.8 w / w%, approximately 24.9 w / w%, approximately 25.0 w / w%, approximately 25.1 w / w%, approximately 25.2 w / w%, approximately 25.3 w / w%, approximately 25.4 w / w%, approximately 25.5 w / w%, approximately 25.6w / w%, approximately 25.7w / w%, approximately 25.8w / w%, approximately 25.9w / w%, approximately 26.0w / w%, approximately 26.1w / w%, approximately 26.2w / w%, approximately 26.3w / w%, approximately 26.4w / w%, approximately 26.5w / w%, approximately 26.6w / w%, approximately 26.7w / w%, approximately 26.8w / w%, approximately 26.9w / w%, approximately 27.0w / w%, approximately 27.1w / w%, approximately 27.2w / w%, approximately 27.3 The amounts are w / w%, approximately 27.4 w / w%, approximately 27.5 w / w%, approximately 27.6 w / w%, approximately 27.7 w / w%, approximately 27.8 w / w%, approximately 27.9 w / w%, approximately 28.0 w / w%, approximately 28.1 w / w%, approximately 28.2 w / w%, approximately 28.3 w / w%, approximately 28.4 w / w%, approximately 28.5 w / w%, approximately 28.6 w / w%, approximately 28.7 w / w%, approximately 28.8 w / w%, approximately 28.9 w / w%, or approximately 29.0 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is approximately 23.4 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is approximately 23.41 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is approximately 27.47 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is approximately 27.5 w / w%.

[0138] In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 21.1 w / w% to about 27.5 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 21.13 w / w% to about 27.47 w / w%.

[0139] In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 21.1 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 21.13 w / w%.

[0140] In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 35 w / w% to about 75 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 45 w / w% to about 65 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 48 w / w% to about 60 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 50 w / w% to about 59 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 50.1 w / w% to about 58.8 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 50.13 w / w% to about 58.84 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 45 w / w%, about 46 w / w%, about 47 w / w%, about 48 w / w%, about 49 w / w%, and about 50 The amounts are w / w%, approximately 51 w / w%, approximately 52 w / w%, approximately 53 w / w%, approximately 54 w / w%, approximately 55 w / w%, approximately 56 w / w%, approximately 57 w / w%, approximately 58 w / w%, approximately 59 w / w%, approximately 60 w / w%, approximately 61 w / w%, approximately 62 w / w%, approximately 63 w / w%, approximately 64 w / w%, or approximately 65 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is approximately 50.1 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is approximately 50.13 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 58.8 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 58.84 w / w%.

[0141] In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 45.3 w / w% to about 58.8 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 45.25 w / w% to about 58.84 w / w%.

[0142] In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 45.25 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 45.3 w / w%.

[0143] In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 5 w / w% to about 35 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 10 w / w% to about 30 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 11 w / w% to about 28 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 13 w / w% to about 27 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 13.69 w / w% to about 26.46 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 13.7 w / w% to about 26.5 w / w%.In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is approximately 13.0 w / w%, approximately 13.1 w / w%, approximately 13.2 w / w%, approximately 13.3 w / w%, approximately 13.4 w / w%, approximately 13.5 w / w%, approximately 13.6 w / w%, and approximately 13. 7 w / w%, approximately 13.8 w / w%, approximately 13.9 w / w%, approximately 14.0 w / w%, approximately 14.1 w / w%, approximately 14.2 w / w%, approximately 14.3 w / w%, approximately 14.4 w / w%, approximately 14.5 w / w%, approximately 14.6 w / w%, approximately 14.7 w / w%, approximately 14.8 w / w%, approximately 14.9 w / w%, approximately 15.0 w / w%, approximately 15. 1 w / w%, approximately 15.2 w / w%, approximately 15.3 w / w%, approximately 15.4 w / w%, approximately 15.5 w / w%, approximately 15.6 w / w%, approximately 15.7 w / w%, approximately 15.8 w / w%, approximately 15.9 w / w%, approximately 16.0 w / w%, approximately 16.1 w / w%, approximately 16.2 w / w%, approximately 16.3 w / w%, approximately 16.4 w / w%, approximately 16. 5 w / w%, approximately 16.6 w / w%, approximately 16.7 w / w%, approximately 16.8 w / w%, approximately 16.9 w / w%, approximately 17.0 w / w%, approximately 17.1 w / w%, approximately 17.2 w / w%, approximately 17.3 w / w%, approximately 17.4 w / w%, approximately 17.5 w / w%, approximately 17.6 w / w%, approximately 17.7 w / w%, approximately 17.8 w / w%, approximately 17. 9w / w%, approx. 18.0w / w%, approx. 18.1w / w%, approx. 18.2w / w%, approx. 18.3w / w%, approx. 18.4w / w%, approx. 18.5w / w%, approx. 18.6w / w%, approx. 18.7w / w%, approx. 18.8w / w%, approx. 18.9w / w%, approx. 19.0w / w%, approx. 19.1w / w% Approximately 19.2 w / w%, 19.3 w / w%, 19.4 w / w%, 19.5 w / w%, 19.6 w / w%, 19.7 w / w%, 19.8 w / w%, 19.9 w / w%, 20.0 w / w%, 21.1 w / w%, 21.2 w / w%, 21.3 w / w%, and 21. 4 w / w%, approximately 21.5 w / w%, approximately 21.6 w / w%, approximately 21.7 w / w%, approximately 21.8 w / w%, approximately 21.9 w / w%, approximately 22.0 w / w%, approximately 22.1 w / w%, approximately 22.2 w / w%, approximately 22.3 w / w%, approximately 22.4 w / w%, approximately 22.5 w / w%, approximately 22.6 w / w% Approximately 22.7 w / w%, 22.8 w / w%, 22.9 w / w%, 23.0 w / w%, 23.1 w / w%, 23.2 w / w%, 23.3 w / w%, 23.4 w / w%, 23.5 w / w%, 23.6 w / w%, 23.7 w / w%, 23.8 w / w%, and 23. 9w / w%, approx. 24.0w / w%, approx. 24.1w / w%, approx. 24.2w / w%, approx. 24.3w / w%, approx. 24.4w / w%, approx. 24.5w / w%, approx. 24.6w / w%, approx. 24.7w / w%, approx. 24.8w / w%, approx. 24.9w / w%, approx. 25.0w / w%, approx. 25.1w / w% Approximately 25.2 w / w%, 25.3 w / w%, 25.4 w / w%, 25.5 w / w%, 25.6 w / w%, 25.7 w / w%, 25.8 w / w%, 25.9 w / w%, 26.0 w / w%, 26.1 w / w%, 26.2 w / w%, 26.3 w / w%, and 26. 4 w / w%, approximately 26.5 w / w%, approximately 26.6 w / w%, approximately 26.7 w / w%, approximately 26.8 w / w%, approximately 26.9 w / w%, approximately 27.0 w / w%, approximately 27.1 w / w%, approximately 27.2 w / w%, approximately 27.3 w / w%, approximately 27.4 w / w%, approximately 27.5 w / w%, approximately 27.6 w / w% Approximately 27.7 w / w%, 27.8 w / w%, 27.9 w / w%, 28.0 w / w%, 28.1 w / w%, 28.2 w / w%, 28.3 w / w%, 28.4 w / w%, 28.5 w / w%, 28.6 w / w%, 28.7 w / w%, 28.8 w / w%, and 28.The amount is 9 w / w%, or approximately 29.0 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is approximately 13.69 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is approximately 13.7 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is approximately 26.46 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is approximately 26.5 w / w%.

[0144] In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 13.69 w / w% to about 33.61 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 13.7 w / w% to about 33.6 w / w%.

[0145] In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 33.61 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, and water is about 33.6 w / w%.

[0146] In some embodiments, the solution contains about 10 w / w% to about 40 w / w% water, about 35 w / w% to about 75 w / w% PEG300, and about 5 w / w% to about 35 w / w% sodium salt of the compound of formula (Ia). In some embodiments, the solution contains about 15 w / w% to about 35 w / w% water, about 45 w / w% to about 65 w / w% PEG300, and about 10 w / w The solution contains approximately 30 w / w% of the sodium salt of the compound of formula (Ia). In some embodiments, the solution contains approximately 20 w / w% to 30 w / w% of water, approximately 48 w / w% to 60 w / w% of PEG300, and approximately 11 w / w% to 28 w / w% of the sodium salt of the compound of formula (Ia). In some embodiments, the solution contains approximately 21 w / w% to 29 w / w% of water, approximately 50 w / w% to 59 w / w% of PEG300, and approximately 13 w / w% to 27 w / w% of the sodium salt of the compound of formula (Ia). In some embodiments, the solution contains about 23.4 w / w% to about 27.5 w / w% water, about 50.1 w / w% to about 58.8 w / w% PEG300, and about 13.7 w / w% to about 26.5 w / w% sodium salt of the compound of formula (Ia). In some embodiments, the solution contains about 23.41 w / w% to about 27.47 w / w% water, about 50.13 w / w% to about 58.84 w / w% PEG300, and about 13.69 w / w% to about 26.46 w / w% sodium salt of the compound of formula (Ia). In some embodiments, the solution contains about 27.5 w / w% water, about 58.8 w / w% PEG300, and about 13.7 w / w% sodium salt of the compound of formula (Ia). In some embodiments, the solution contains about 27.47 w / w% water, about 58.84 w / w% PEG300, and about 13.69 w / w% sodium salt of the compound of formula (Ia). In some embodiments, the solution contains about 23.4 w / w% water, about 50.1 w / w% PEG300, and about 26.5 w / w% sodium salt of the compound of formula (Ia). In some embodiments, the solution contains about 23.41 w / w% water, about 50.13 w / w% PEG300, and about 26.46 w / w% sodium salt of the compound of formula (Ia).

[0147] In some embodiments, the solution contains about 10 w / w% to about 40 w / w% water, about 35 w / w% to about 75 w / w% PEG300, and about 5 w / w% to about 45 w / w% sodium salt of the compound of formula (Ia). In some embodiments, the solution contains about 10 w / w% to about 30 w / w% water, about 35 w / w% to about 65 w / w% PEG300, and about 5 w / w% to about 45 w / w% sodium salt of the compound of formula (Ia).

[0148] In some embodiments, the solution contains about 21.1 w / w% to about 27.5 w / w% water, about 45.3 w / w% to about 58.8 w / w% PEG300, and about 13.7 w / w% to about 33.6 w / w% sodium salt of the compound of formula (Ia). In some embodiments, the solution contains about 21.13 w / w% to about 27.47 w / w% water, about 45.25 w / w% to about 58.84 w / w% PEG300, and about 13.69 w / w% to about 33.61 w / w% sodium salt of the compound of formula (Ia).

[0149] In some embodiments, the solution comprises about 21.1 w / w% water, about 45.3 w / w% PEG300, and about 33.6 w / w% sodium salt of the compound of formula (Ia). In some embodiments, the solution comprises about 21.13 w / w% water, about 45.25 w / w% PEG300, and about 33.61 w / w% sodium salt of the compound of formula (Ia).

[0150] In some embodiments, the solution comprises a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, PEG300, water, and ethanol. In some embodiments, the solution comprises a compound of formula (Ia), or a pharmaceutically acceptable salt thereof, PEG300, water, and ethanol. In some embodiments, the solution comprises a sodium salt of the compound of formula (Ia), PEG300, water, and ethanol. In some embodiments, the solution comprises a compound of formula (Ib), or a pharmaceutically acceptable salt thereof, PEG300, water, and ethanol.

[0151] In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, and ethanol is about 10 w / w% to about 20 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, and ethanol is about 12 w / w% to about 20 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, and ethanol is approximately 16.93 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, and ethanol is approximately 16.9 w / w%.

[0152] In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, and ethanol is about 30 w / w% to about 40 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, and ethanol is about 32 w / w% to about 40 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, and ethanol is about 36.22 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, and ethanol is about 36.2 w / w%.

[0153] In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, and ethanol is about 35 w / w% to about 45 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, and ethanol is about 37 w / w% to about 45 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, and ethanol is about 41.85 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, and ethanol is about 41.9 w / w%.

[0154] In some embodiments, the amount of ethanol in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, and ethanol is about 0.1 w / w% to about 10 w / w%. In some embodiments, the amount of ethanol in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, and ethanol is about 1 w / w% to about 9 w / w%. In some embodiments, the amount of ethanol in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, and ethanol is about 3 w / w% to about 8 w / w%. In some embodiments, the amount of ethanol in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, and ethanol is about 5.00 w / w%. In some embodiments, the amount of ethanol in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, and ethanol is about 5.0 w / w%.

[0155] In some embodiments, the solution comprises about 10 w / w% to about 40 w / w% water, about 20 w / w% to about 75 w / w% PEG300, about 10 w / w% to about 70 w / w% sodium salt of the compound of formula (Ia), and about 1 w / w% to about 9 w / w% ethanol. In some embodiments, the solution comprises about 10 w / w% to about 20 w / w% water, about 30 w / w% to about 40 w / w% PEG300, about 37 w / w% to about 45 w / w% sodium salt of the compound of formula (Ia), and about 3 w / w% to about 8 w / w% ethanol.

[0156] In some embodiments, the solution comprises about 16.93 w / w% water, about 36.22 w / w% PEG300, about 41.85 w / w% sodium salt of the compound of formula (Ia), and about 5.00 w / w% ethanol. In some embodiments, the solution comprises about 16.9 w / w% water, about 36.2 w / w% PEG300, about 41.9 w / w% sodium salt of the compound of formula (Ia), and about 5.0 w / w% ethanol.

[0157] In some embodiments, the solution comprises a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, PEG300, poloxamer 188, and water. In some embodiments, the solution comprises the compound of formula (Ia) or a pharmaceutically acceptable salt thereof, PEG300, poloxamer 188, and water. In some embodiments, the solution comprises the compound of formula (Ib) or a pharmaceutically acceptable salt thereof, PEG300, poloxamer 188, and water. In some embodiments, the solution comprises the compound of formula (Ia), PEG300, poloxamer 188, and water. In some embodiments, the solution comprises the compound of formula (Ib), PEG300, poloxamer 188, and water.

[0158] In some embodiments, the solution comprises the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water. In some embodiments, the concentration of the compound of formula (Ia) in the solution comprising the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 50 mg / mL to about 500 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in the solution comprising the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 50 mg / mL to about 400 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in the solution comprising the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 50 mg / mL to about 300 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 75 mg / mL to about 300 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 50 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 75 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 100 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 125 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 150 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 175 mg / mL.In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 200 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 225 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 250 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 275 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 300 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 325 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 350 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 375 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 400 mg / mL. In some embodiments, the solution contains the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water. The concentration of the compound of formula (Ia) in a solution is approximately 425 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 450 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 475 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 500 mg / mL.

[0159] In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 10 w / w% to about 45 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 15 w / w% to about 35 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 20 w / w% to about 35 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 20 w / w% to about 31 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 21.9 w / w% to about 30.1 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 21.87 w / w% to about 30.07 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 19.0 w / w%, approximately 19.1 w / w%, approximately 19.2 w / w%, approximately 19.3 w / w%, approximately 19.4 w / w%, approximately 19.5 w / w%, approximately 19.6 w / w%, approximately 19.7 w / w%, approximately 19.8 w / w%, approximately 19.9 w / w%, approximately 20.0 w / w%, approximately 20.1 w / w%, approximately 20.2 w / w%, approximately 20.3 w / w%, approximately 20.4 w / w%, approximately 20.5 w / w%, approximately 20.6 w / w%, approximately 20.7 w / w%, approximately 20.8 w / w%, approximately 20.9w / w%, approx. 21.0w / w%, approx. 21.1w / w%, approx. 21.2w / w%, approx. 21.3w / w%, approx. 21.4w / w%, approx. 21. 5w / w%, approx. 21.6w / w%, approx. 21.7w / w%, approx. 21.8w / w%, approx. 21.9w / w%, approx. 22.0w / w%, approx. 22.1w / w%, approximately 22.2 w / w%, approximately 22.3 w / w%, approximately 22.4 w / w%, approximately 22.5 w / w%, approximately 22.6 w / w%, approximately 22.7 w / w%, approximately 22.8 w / w%, approximately 22.9 w / w%, approximately 23.0 w / w%, approximately 23.1 w / w%, approximately 23.2 w / w%, approximately 23.3 w / w%, approximately 23.4 w / w%, approximately 23.5 w / w%, approximately 23.6 w / w%, approximately 23.7 w / w%, approximately 23.8 w / w%, approximately 23.9 w / w%, approximately 24.0 w / w%, approximately 24.1 w / w%, approximately 24.2 w / w%, approximately 24.3 w / w%, approximately 24.4 w / w%, approximately 24.5 w / w%, approximately 24.6 w / w%, approximately 24.7 w / w%, approximately 24.8 w / w%, approximately 24.9 w / w%, approximately 25.0 w / w%, approximately 25.1w / w%, approximately 25.2w / w%, approximately 25.3w / w%, approximately 25.4w / w%, approximately 25.5w / w%, approximately 25.6w / w%, approximately 25.7w / w%, approximately 25.8w / w%, approximately 25.9w / w%, approximately 26.0w / w%, approximately 26.1w / w%, approximately 26.2w / w%, approximately 26.3w / w%, approximately 26.4w / w%, approximately 26.5w / w%, approximately 26.6w / w%, approximately 26.7w / w%, approximately 26.8w / w%, approximately 26.9w / w%, approximately 27.0w / w%, approximately 27.1w / w%, approximately 27.2w / w%, approximately 27.3w / w%, approximately 27.4w / w%, approximately 27.5w / w%, approximately 27.6w / w%, approximately 27.7w / w%, approximately 27.8w / w%, approximately 27.9w / w%, approximately 28.0w / w%, approximately 28.1w / w%, approximately 28.2w / w%, approximately 28.3 w / w%, approximately 28.4 w / w%, approximately 28.5 w / w%, approximately 28.6 w / w%, approximately 28.7 w / w%, approximately 28.8 w / w%, approximately 28.9 w / w%, approximately 29.0 w / w%, approximately 29.1 w / w%, approximately 29.2 w / w%, approximately 29.3 w / w%, approximately 29.4 w / w%, approximately 29.5 w / w%, approximately 29.6 w / w%, approximately 29.7 w / w%, approximately 29.8 w / w. %, approx. 29.9w / w%, approx. 30.0w / w%, approx. 30.1w / w%, approx. 30.2w / w%, approx. 30.3w / w%, approx. 30.4w / w%, approx. 30.5w / w%, approx. 30.6w / w% , about 30.7w / w%, about 30.8w / w%, about 30.9w / w%, about 31.0w / w%, about 31.1w / w%, about 31.2w / w%, about 31.3w / w%, about 31.4w / w%, about The amounts are approximately 31.5 w / w%, 31.6 w / w%, 31.7 w / w%, 31.8 w / w%, 31.9 w / w%, 32.0 w / w%, 32.1 w / w%, 32.2 w / w%, 32.3 w / w%, 32.4 w / w%, 32.5 w / w%, 32.6 w / w%, 32.7 w / w%, 32.8 w / w%, 32.9 w / w%, or 33.0 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 21.87 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 21.9 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 26.68 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 26.7 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 27.5 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 27.51 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 28.36 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 28.4 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 29.2 w / w%.In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 29.21 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 30.07 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 30.1 w / w%.

[0160] In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 19.18 w / w% to about 30.07 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 19.2 w / w% to about 30.1 w / w%.

[0161] In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 19.18 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 19.2 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 20.16 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 20.2 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 22.10 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 22.1 w / w%. In some embodiments, the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 22.1 w / w%. In some embodiments, the amount of water in a solution containing PEG300, poloxamer 188, and water is approximately 22.48 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 22.5 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 22.85 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 22.9 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 23.22 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 23.2 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 26.79 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 26.8 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 27.61 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 27.6 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 28.43 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 28.4 w / w%.

[0162] In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 30 w / w% to about 85 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 35 w / w% to about 75 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 40 w / w% to about 70 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 45 w / w% to about 68 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 46.84 w / w% to about 64.4 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 46.84 w / w% to about 64.40 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 40 w / w%, approximately 41 w / w%, approximately 42 w / w%, approximately 43 w / w%, approximately 44 w / w%, approximately 45 w / w%, approximately 46 w / w%, approximately 47 w / w%, approximately 48 w / w%, approximately 49 w / w%, approximately 50 w / w%, and approximately 51 w / w%. The amounts are approximately w%, 52 w / w%, 53 w / w%, 54 w / w%, 55 w / w%, 56 w / w%, 57 w / w%, 58 w / w%, 59 w / w%, 60 w / w%, 61 w / w%, 62 w / w%, 63 w / w%, 64 w / w%, 65 w / w%, 66 w / w%, 67 w / w%, 68 w / w%, 69 w / w%, or 70 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 46.8 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 46.84 w / w%.In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 57.1 w / w%. In one embodiment, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 57.13 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 58.9 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 58.92 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 60.7 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 60.73 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 62.55 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 62.6 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 64.4 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 64.40 w / w%.

[0163] In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 41.09 w / w% to about 64.40 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 41.1 w / w% to about 64.4 w / w%.

[0164] In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 41.09 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 41.1 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 43.17 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 43.2 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 47.33 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 47.3 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 48.13 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 48.1 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 48.94 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 48.9 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 49.73 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 49.7 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188 In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 57.38 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 57.4 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 59.13 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 59.1 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 60.90 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 60.9 w / w%.

[0165] In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 0.5 w / w% to about 40 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 1 w / w% to about 35 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 1 w / w% to about 30 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 3 w / w% to about 28 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 4 w / w% to about 27 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 4.68 w / w% to about 26.47 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 4.7 w / w% to about 26.5 w / w%.In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 3.0 w / w%, approximately 3.1 w / w%, approximately 3.2 w / w%, approximately 3.3 w / w%, approximately 3.4 w / w%, approximately 3.5 w / w%, approximately 3.6 w / w%, approximately 3.7 w / w%, approximately 3.8 w / w%, approximately 3.9 w / w%, approximately 4.0 w / w%, approximately 4.1 w / w%, approximately 4.2 w / w%, approximately 4.3 w / w%, approximately 4.4 w / w%, approximately 4.5w / w%, approximately 4.6w / w%, approximately 4.7w / w%, approximately 4.8w / w%, approximately 4.9w / w%, approximately 5.0w / w%, approximately 5.1w / w%, approximately 5.2w / w%, approximately 5.3w / w%, approximately 5.4w / w%, approximately 5.5w / w%, approximately 5.6w / w%, approximately 5.7w / w%, approximately 5.8w / w%, approximately 5.9w / w%, approximately 6.0w / w%, approximately 6.1w / w%, approximately 6.2w / w%, approximately 6.3w / w%, approximately 6.4w / w%, approximately 6.5w / w%, approximately 6.6w / w%, approximately 6.7w / w%, approximately 6.8w / w %, about 6.9w / w%, about 7.0w / w%, about 7.1w / w%, about 7.2w / w%, about 7.3w / w%, about 7.4w / w%, about 7.5w / w%, about 7.6w / w%, about 7.7w / w%, about 7.8w / w%, about 7.9w / w%, about 8.0w / w%, approximately 8.1w / w%, approximately 8.2w / w%, approximately 8.3w / w%, approximately 8.4w / w%, approximately 8.5w / w%, approximately 8.6w / w%, approximately 8.7w / w%, approximately 8.8w / w%, approximately 8.9w / w%, approximately 9.0w / w%, approximately 9.1w / w%, approximately 9. 2w / w%, approximately 9.3w / w%, approximately 9.4w / w%, approximately 9.5w / w%, approximately 9.6w / w%, approximately 9.7w / w%, approximately 9.8w / w%, approximately 9.9w / w%, approximately 10.0w / w%, approximately 10.1w / w%, approximately 10.2w / w%, approximately 10.3w / w%, approximately 10.4w / w%, approximately 10.5w / w%, approximately 10.6w / w%, approximately 10.7w / w%, approximately 10.8w / w%, approximately 10.9w / w%, approximately 11.0w / w%, approximately 11.1w / w%, approximately 11.2w / w%, approximately 11.3w / w%, approximately 11. 0.4 w / w%, approximately 11.5 w / w%, approximately 11.6 w / w%, approximately 11.7 w / w%, approximately 11.8 w / w%, approximately 11.9 w / w%, approximately 12.0 w / w%, approximately 12.1 w / w%, approximately 12.2 w / w%, approximately 12.3 w / w%, approximately 12.4 w / w%, approximately 12.5 w / w%, approximately 12.6 w / w %, approximately 12.7 w / w%, approximately 12.8 w / w%, approximately 12.9 w / w%, approximately 13.0 w / w%, approximately 13.1 w / w%, approximately 13.2 w / w%, approximately 13.3 w / w%, approximately 13.4 w / w%, approximately 13.5 w / w%, approximately 13.6 w / w%, approximately 13.7 w / w%, approximately 13.8 w / w%, approximately 13 .9w / w%, approx. 14.0w / w%, approx. 14.1w / w%, approx. 14.2w / w%, approx. 14.3w / w%, approx. 14.4w / w%, approx. 14.5 w / w%, approx. 14.6w / w%, approx. 14.7w / w%, approx. 14.8w / w%, approx. 14.9w / w%, approx. 15.0w / w%, approx. 15.1w / w %, approximately 15.2 w / w%, approximately 15.3 w / w%, approximately 15.4 w / w%, approximately 15.5 w / w%, approximately 15.6 w / w%, approximately 15.7 w / w%, approximately 15.8 w / w%, approximately 15.9 w / w%, approximately 16.0 w / w%, approximately 16.1 w / w%, approximately 16.2 w / w%, approximately 16.3 w / w%, approximately 16 0.4w / w%, approximately 16.5w / w%, approximately 16.6w / w%, approximately 16.7w / w%, approximately 16.8w / w%, approximately 16.9w / w%, approximately 17.0w / w%, approximately 17.1w / w%, approximately 17.2w / w%, approximately 17.3w / w%, approximately 17.4w / w%, approximately 17.5w / w%, approximately 17.6w / w %, approximately 17.7 w / w%, approximately 17.8 w / w%, approximately 17.9 w / w%, approximately 18.0 w / w%, approximately 18.1 w / w%, approximately 18.2 w / w%, approximately 18.3 w / w%, approximately 18.4 w / w%, approximately 18.5 w / w%, approximately 18.6 w / w%, approximately 18.7 w / w%, approximately 18.8 w / w%, approximately 18 .9w / w%, approx. 19.0w / w%, approx. 19.1w / w%, approx. 19.2w / w%, approx. 19.3w / w%, approx. 19.4w / w%, approx. 19.5 w / w%, approx. 19.6w / w%, approx. 19.7w / w%, approx. 19.8w / w%, approx. 19.9w / w%, approx. 20.0w / w%, approx. 20.1w / w %, approximately 20.2 w / w%, approximately 20.3 w / w%, approximately 20.4 w / w%, approximately 20.5 w / w%, approximately 20.6 w / w%, approximately 20.7 w / w%, approximately 20.8 w / w%, approximately 20.9 w / w%, approximately 21.0 w / w%, approximately 21.1 w / w%, approximately 21.2 w / w%, approximately 21.3 w / w%, approximately 21.4w / w%, approximately 21.5w / w%, approximately 21.6w / w%, approximately 21.7w / w%, approximately 21.8w / w%, approximately 21.9w / w%, approximately 22.0w / w%, approximately 22.1w / w%, approximately 22.2w / w%, approximately 22.3w / w%, approximately 22.4w / w%, approximately 22.5w / w%, approximately 22.6w / w%, approximately 22.7w / w%, approximately 22.8w / w%, approximately 22.9w / w%, approximately 23.0w / w%, approximately 23.1w / w%, approximately 23.2w / w%, approximately 23.3w / w%, approximately 23.4w / w%, approximately 23.5w / w%, approximately 23.6w / w%, approximately 23.7w / w%, approximately 23.8w / w%, approximately 23.9w / w%, approximately 24.0w / w%, approximately 24.1w / w%, approximately 24.2w / w%, approximately 24.3w / w%, approximately 24.4w / w%, approximately 24.5w / w%, approximately 24.6w / w%, approximately 24.7w / w%, approximately 24.8w / w%, approximately 24.9w / w%, approximately 25.0w / w%, approximately 25.1w / w%, approximately 25.2w / w% Approximately 25.3 w / w%, approximately 25.4 w / w%, approximately 25.5 w / w%, approximately 25.6 w / w%, approximately 25.7 w / w%, approximately 25.8 w / w%, approximately 25.9 w / w%, approximately 26.0 w / w%, approximately 26.1 w / w%, approximately 26.2 w / w%, approximately 26.3 w / w%, approximately 26.4 w / w%, approximately 26.5 w / w%, approximately 26.6 w / w%, approximately 26.7 w / w%, approximately 26.8 w / w%, approximately 26.9 w / w%, approximately 27.0 w / w%, approximately 27.1 w / w%, approximately 2 The amounts are approximately 7.2 w / w%, about 27.3 w / w%, about 27.4 w / w%, about 27.5 w / w%, about 27.6 w / w%, about 27.7 w / w%, about 27.8 w / w%, about 27.9 w / w%, about 28.0 w / w%, about 28.1 w / w%, about 28.2 w / w%, about 28.3 w / w%, about 28.4 w / w%, about 28.5 w / w%, about 28.6 w / w%, about 28.7 w / w%, about 28.8 w / w%, about 28.9 w / w%, or about 29.0 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 4.68 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 4.7 w / w%. The amount of sodium salt of the compound of formula (Ia) in a solution is approximately 6.97 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 7 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 9.2 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 9.23 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 11.48 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 11.5 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 13.7 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 13.70 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 26.47 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing PEG300, poloxamer 188, and water is approximately 26.5 w / w%.

[0166] In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 4.68 w / w% to about 33.61 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 4.7 w / w% to about 33.6 w / w%.

[0167] In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 9.03 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 9.0 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 11.22 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 11.2 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 13.39 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 13.4 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 25.85 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 25.87 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 25.9 w / w%. The amount is approximately 33.61 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 33.6 w / w%.

[0168] In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 0.1 w / w% to about 10 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 0.3 w / w% to about 8 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 0.5 w / w% to about 7 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 0.6 w / w% to about 7 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 0.85 w / w% to about 4.82 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 0.9 w / w% to about 4.8 w / w%.In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 0.5 w / w%, approximately 0.6 w / w%, approximately 0.7 w / w%, approximately 0.8 w / w%, approximately 0.9 w / w%, approximately 1.0 w / w%, approximately 1.1 w / w%, approximately 1.2 w / w%, approximately 1.3 w / w%, approximately 1.4 w / w%, and approximately 1.5 w / w%. Approximately 1.6 w / w%, approximately 1.7 w / w%, approximately 1.8 w / w%, approximately 1.9 w / w%, approximately 2.0 w / w%, approximately 2.1 w / w%, approximately 2.2 w / w%, approximately 2.3 w / w%, approximately 2.4 w / w%, approximately 2.5 w / w%, approximately 2.6 w / w%, approximately 2.7 w / w%, approximately 2.8 w / w%, approximately 2.9 w / w%, approximately 3.0 w / w%, approximately 3.1 w / w%, approximately 3.2 w / w%, approximately 3.3 w / w%, approximately 3.4 w / w%, approximately 3.5 w / w%, approximately 3.6 w / w%, approximately 3.7 w / w%, approximately 3.8 w / w%, approximately 3.9 w / w%, approximately 4.0 w / w%, approximately 4.1 w / w%, approximately 4.2 w / w%, approximately 4.3 w / w%, approximately 4.4 w / w%, approximately 4.5 w / w%, approximately 4.6 w / w%, approximately 4.7 w / w%, approximately 4.8 w / w%, approximately 4.9 w / w%, approximately 5.0 w / w%, approximately 5.1 w / w%, approximately 5.2 w / w%, The amounts are approximately 5.3 w / w%, 5.4 w / w%, 5.5 w / w%, 5.6 w / w%, 5.7 w / w%, 5.8 w / w%, 5.9 w / w%, 6.0 w / w%, 6.1 w / w%, 6.2 w / w%, 6.3 w / w%, 6.4 w / w%, 6.5 w / w%, 6.6 w / w%, 6.7 w / w%, 6.8 w / w%, 6.9 w / w%, or 7.0 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 0.85 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 0.9 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 1.27 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 1.3 w / w%.In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 1.68 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 1.7 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 2.09 w / w%. In some embodiments, poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water. The amount is approximately 2.1 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 2.49 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 2.5 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 4.8 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is approximately 4.82 w / w%.

[0169] In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 0.85 w / w% to about 6.12 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 0.9 w / w% to about 6.1 w / w%.

[0170] In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 1.18 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 1.2 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 1.64 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 1.6 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 2.04 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 2.0 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 2.36 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 2.44 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 2.4 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 3.06 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 3.1 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 3.54 w / w%.In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 3.5 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 4.72 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 4.7 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water is about 6.12 w / w%. In some embodiments, a solution containing the sodium salt of the compound of formula (Ia), PEG300, poloxamer 188, and water. The amount of poloxamer 188 in the mixture is approximately 6.1 w / w%.

[0171] In some embodiments, the solution comprises about 10 w / w% to about 45 w / w% water, about 30 w / w% to about 85 w / w% PEG300, about 0.5 w / w% to about 40 w / w% sodium salt of the compound of formula (Ia), and about 0.1 w / w% to about 10 w / w% poloxamer 188. In some embodiments, the solution comprises about 15 w / w% to about 35 w / w% water, about 35 w / w% to about 75 w / w% PEG300, about 1 w / w% to about 35 w / w% sodium salt of the compound of formula (Ia), and about 0.3 w / w% to about 8 w / w% poloxamer 188. In some embodiments, the solution contains about 20 w / w% to about 35 w / w% water, about 40 w / w% to about 70 w / w% PEG300, about 1 w / w% to about 30 w / w% sodium salt of the compound of formula (Ia), and about 0.5 w / w% to about 7 w / w% poloxamer 188. In some embodiments, the solution contains about 20 w / w% to about 31 w / w% water, about 45 w / w% to about 68 w / w% PEG300, about 3 w / w% to about 28 w / w% sodium salt of the compound of formula (Ia), and about 0.6 w / w% to about 7 w / w% poloxamer 188. In some embodiments, the solution comprises about 21.9 w / w% to about 30.1 w / w% water, about 46.8 w / w% to about 64.4 w / w% PEG300, about 4.7 w / w% to about 26.5 w / w% sodium salt of the compound of formula (Ia), and about 0.9 w / w% to about 4.8 w / w% poloxamer 188. In some embodiments, the solution comprises about 21.87 w / w% to about 30.07 w / w% water, about 46.84 w / w% to about 64.40 w / w% PEG300, about 4.68 w / w% to about 26.47 w / w% sodium salt of the compound of formula (Ia), and about 0.85 w / w% to about 4.82 w / w% poloxamer 188. In some embodiments, the solution comprises about 30.1 w / w% water, about 64.4 w / w% PEG300, about 4.7 w / w% sodium salt of the compound of formula (Ia), and about 0.9 w / w% poloxamer 188. In some embodiments, the solution comprises about 30.07 w / w% water, about 64.40 w / w% PEG300, about 4.68 w / w% sodium salt of the compound of formula (Ia), and about 0.85 w / w% poloxamer 188.In some embodiments, the solution comprises about 29.2 w / w% water, about 62.6 w / w% PEG300, about 7 w / w% sodium salt of the compound of formula (Ia), and about 1.3 w / w% poloxamer 188. In some embodiments, the solution comprises about 29.21 w / w% water, about 62.55 w / w% PEG300, about 6.97 w / w% sodium salt of the compound of formula (Ia), and about 1.27 w / w% poloxamer 188. In some embodiments, the solution comprises about 28.4 w / w% water, about 60.7 w / w% PEG300, about 9.2 w / w% sodium salt of the compound of formula (Ia), and about 1.7 w / w% poloxamer 188. In some embodiments, the solution comprises about 28.36 w / w% water, about 60.73 w / w% PEG300, about 9.23 w / w% sodium salt of the compound of formula (Ia), and about 1.68 w / w% poloxamer 188. In some embodiments, the solution comprises about 27.5 w / w% water, about 58.9 w / w% PEG300, about 11.5 w / w% sodium salt of the compound of formula (Ia), and about 2.1 w / w% poloxamer 188. In some embodiments, the solution comprises about 27.51 w / w% water, about 58.92 w / w% PEG300, about 11.48 w / w% sodium salt of the compound of formula (Ia), and about 2.09 w / w% poloxamer 188. In some embodiments, the solution comprises about 26.7 w / w% water, about 57.1 w / w% PEG300, about 13.7 w / w% sodium salt of the compound of formula (Ia), and about 2.5 w / w% poloxamer 188. In some embodiments, the solution comprises about 26.68 w / w% water, about 57.13 w / w% PEG300, about 13.70 w / w% sodium salt of the compound of formula (Ia), and about 2.49 w / w% poloxamer 188. In some embodiments, the solution comprises about 21.9 w / w% water, about 46.8 w / w% PEG300, about 26.5 w / w% sodium salt of the compound of formula (Ia), and about 4.8 w / w% poloxamer 188. In some embodiments, the solution consists of about 21.87 w / w% water, about 46.84 w / w% PEG300, about 26.47 w / w% sodium salt of the compound of formula (Ia), and about 4.82 w / w% poloxama. -188 is included.

[0172] In some embodiments, the solution contains about 19.2 w / w% to about 30.1 w / w% water, about 41.1 w / w% to about 64.4 w / w% PEG300, about 4.7 w / w% to about 33.6 w / w% sodium salt of the compound of formula (Ia), and about 0.9 w / w% to about 6.1 w / w% poloxamer 188. In some embodiments, the solution contains about 19.18 w / w% to about 30.07 w / w% water, about 41.09 w / w% to about 64.40 w / w% PEG300, about 4.68 w / w% to about 33.61 w / w% sodium salt of the compound of formula (Ia), and about 0.85 w / w% to about 6.12 w / w% poloxamer 188.

[0173] In some embodiments, the solution comprises about 28.4 w / w% water, about 60.9 w / w% PEG300, about 9.0 w / w% sodium salt of the compound of formula (Ia), and about 1.6 w / w% poloxamer 188. In some embodiments, the solution comprises about 28.43 w / w% water, about 60.90 w / w% PEG300, about 9.03 w / w% sodium salt of the compound of formula (Ia), and about 1.64 w / w% poloxamer 188.

[0174] In some embodiments, the solution comprises about 27.6 w / w% water, about 59.1 w / w% PEG300, about 11.2 w / w% sodium salt of the compound of formula (Ia), and about 2.0 w / w% poloxamer 188. In some embodiments, the solution comprises about 27.61 w / w% water, about 59.13 w / w% PEG300, about 11.22 w / w% sodium salt of the compound of formula (Ia), and about 2.04 w / w% poloxamer 188.

[0175] In some embodiments, the solution comprises about 26.8 w / w% water, about 57.4 w / w% PEG300, about 13.4 w / w% sodium salt of the compound of formula (Ia), and about 2.4 w / w% poloxamer 188. In some embodiments, the solution comprises about 26.79 w / w% water, about 57.38 w / w% PEG300, about 13.39 w / w% sodium salt of the compound of formula (Ia), and about 2.44 w / w% poloxamer 188.

[0176] In some embodiments, the solution comprises about 23.2 w / w% water, about 49.7 w / w% PEG300, about 25.9 w / w% sodium salt of the compound of formula (Ia), and about 1.2 w / w% poloxamer 188. In some embodiments, the solution comprises about 23.22 w / w% water, about 49.73 w / w% PEG300, about 25.87 w / w% sodium salt of the compound of formula (Ia), and about 1.18 w / w% poloxamer 188.

[0177] In some embodiments, the solution comprises about 22.9 w / w% water, about 48.9 w / w% PEG300, about 25.9 w / w% sodium salt of the compound of formula (Ia), and about 2.4 w / w% poloxamer 188. In some embodiments, the solution comprises about 22.85 w / w% water, about 48.94 w / w% PEG300, about 25.85 w / w% sodium salt of the compound of formula (Ia), and about 2.36 w / w% poloxamer 188.

[0178] In some embodiments, the solution comprises about 22.5 w / w% water, about 48.1 w / w% PEG300, about 25.9 w / w% sodium salt of the compound of formula (Ia), and about 3.5 w / w% poloxamer 188. In some embodiments, the solution comprises about 22.48 w / w% water, about 48.13 w / w% PEG300, about 25.85 w / w% sodium salt of the compound of formula (Ia), and about 3.54 w / w% poloxamer 188.

[0179] In some embodiments, the solution comprises about 22.1 w / w% water, about 47.3 w / w% PEG300, about 25.9 w / w% sodium salt of the compound of formula (Ia), and about 4.7 w / w% poloxamer 188. In some embodiments, the solution comprises about 22.10 w / w% water, about 47.33 w / w% PEG300, and about 25.85 w / w% of the compound of formula (Ia). It contains the sodium salt of the compound and approximately 4.72 w / w% poloxamer 188.

[0180] In some embodiments, the solution comprises about 20.2 w / w% water, about 43.2 w / w% PEG300, about 33.6 w / w% sodium salt of the compound of formula (Ia), and about 3.1 w / w% poloxamer 188. In some embodiments, the solution comprises about 20.16 w / w% water, about 43.17 w / w% PEG300, about 33.61 w / w% sodium salt of the compound of formula (Ia), and about 3.06 w / w% poloxamer 188.

[0181] In some embodiments, the solution comprises about 19.2 w / w% water, about 41.1 w / w% PEG300, about 33.6 w / w% sodium salt of the compound of formula (Ia), and about 6.1 w / w% poloxamer 188. In some embodiments, the solution comprises about 19.18 w / w% water, about 41.09 w / w% PEG300, about 33.61 w / w% sodium salt of the compound of formula (Ia), and about 6.12 w / w% poloxamer 188.

[0182] In some embodiments, the solution comprises a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, PEG300, water, poloxamer 188, and ethanol. In some embodiments, the solution comprises a compound of formula (Ia), or a pharmaceutically acceptable salt thereof, PEG300, water, poloxamer 188, and ethanol. In some embodiments, the solution comprises a sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol. In some embodiments, the solution comprises a compound of formula (Ib), or a pharmaceutically acceptable salt thereof, PEG300, water, poloxamer 188, and ethanol.

[0183] In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol is about 10 w / w% to about 20 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol is about 10 w / w% to about 19 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol is about 14.50 w / w% to about 15.71 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol is about 14.5 w / w% to about 15.7 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol is about 14.50 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol is about 14.55 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol is about 14.57 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol is about 14.6 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol is about 15.71 w / w%. In some embodiments, the amount of water in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol is approximately 15.7 w / w%.

[0184] In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol is about 25 w / w% to about 40 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol is about 27 w / w% to about 37 w / w%. In some embodiments, formula (Ia) In a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol, the amount of PEG300 is about 31.04 w / w% to about 33.63 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol is about 31.0 w / w% to about 33.6 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol is about 31.04 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol is about 31.0 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol is about 31.21 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol is about 31.2 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol is about 33.63 w / w%. In some embodiments, the amount of PEG300 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol is about 33.6 w / w%.

[0185] In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol is about 35 w / w% to about 45 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol is about 37 w / w% to about 45 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol is about 41.64 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol is about 41.6 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol is about 41.85 w / w%. In some embodiments, the amount of sodium salt of the compound of formula (Ia) in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol is about 41.9 w / w%.

[0186] In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol is about 0.5 w / w% to about 12 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol is about 1 w / w% to about 11 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol is about 3.81 w / w% to about 7.61 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol is about 3.8 w / w% to about 7.6 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol is about 3.81 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol is about 3.8 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188 The amount of poloxamer 188 in a solution containing M188 and ethanol is approximately 7.58 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol is approximately 7.61 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol is approximately 7.6 w / w%.

[0187] In some embodiments, the amount of ethanol in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol is about 0.1 w / w% to about 10 w / w%. In some embodiments, the amount of ethanol in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol is about 1 w / w% to about 9 w / w%. In some embodiments, the amount of ethanol in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol is about 3 w / w% to about 8 w / w%. In some embodiments, the amount of ethanol in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol is about 5.00 w / w%. In some embodiments, the amount of ethanol in a solution containing the sodium salt of the compound of formula (Ia), PEG300, water, poloxamer 188, and ethanol is about 5.0 w / w%.

[0188] In some embodiments, the solution comprises about 10 w / w% to about 40 w / w% water, about 20 w / w% to about 75 w / w% PEG300, about 10 w / w% to about 70 w / w% sodium salt of the compound of formula (Ia), about 1 w / w% to about 20 w / w% poloxamer 188, and about 1 w / w% to about 10 w / w% ethanol. In some embodiments, the solution comprises about 10 w / w% to about 20 w / w% water, about 25 w / w% to about 35 w / w% PEG300, about 37 w / w% to about 45 w / w% sodium salt of the compound of formula (Ia), and about 3 w / w% to about 8 w / w% ethanol.

[0189] In some embodiments, the solution comprises about 15.71 w / w% water, about 33.63 w / w% PEG300, about 41.85 w / w% sodium salt of the compound of formula (Ia), about 3.81 w / w% poloxamer 188, and about 5.00 w / w% ethanol. In some embodiments, the solution comprises about 15.7 w / w% water, about 33.6 w / w% PEG300, about 41.9 w / w% sodium salt of the compound of formula (Ia), about 3.8 w / w% poloxamer 188, and about 5.0 w / w% ethanol.

[0190] In some embodiments, the solution comprises about 14.57 w / w% water, about 31.21 w / w% PEG300, about 41.64 w / w% sodium salt of the compound of formula (Ia), about 7.58 w / w% poloxamer 188, and about 5.00 w / w% ethanol. In some embodiments, the solution comprises about 14.6 w / w% water, about 31.2 w / w% PEG300, about 41.6 w / w% sodium salt of the compound of formula (Ia), about 7.6 w / w% poloxamer 188, and about 5.0 w / w% ethanol.

[0191] In some embodiments, the solution comprises about 14.50 w / w% water, about 31.04 w / w% PEG300, about 41.85 w / w% sodium salt of the compound of formula (Ia), about 7.61 w / w% poloxamer 188, and about 5.00 w / w% ethanol. In some embodiments, the solution comprises about 14.5 w / w% water, about 31.0 w / w% PEG300, about 41.9 w / w% sodium salt of the compound of formula (Ia), about 7.6 w / w% poloxamer 188, and about 5.0 w / w% ethanol.

[0192] In some embodiments of the methods described herein, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is an aqueous suspension (for example, for SC or IM administration). It is administered as a parenteral formulation. In some embodiments, the parenteral formulation (e.g., SC or IM formulation) is an aqueous suspension comprising a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, and physiological saline. In some embodiments, the parenteral formulation (e.g., SC or IM formulation) is an aqueous suspension comprising a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, physiological saline, and a suspending agent. In some embodiments, the parenteral formulation (e.g., SC or IM formulation) is an aqueous suspension comprising a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, physiological saline, and poloxamer (e.g., poloxamer 338, 188, or 207).

[0193] In some embodiments, a suspension is provided containing poloxamer and a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, in physiological saline. In some embodiments, the concentration of poloxamer in physiological saline is about 0.1% to about 20%. In some embodiments, the concentration of poloxamer in physiological saline is about 0.1% to about 10%. In some embodiments, the concentration of poloxamer in physiological saline is about 0.1%, about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, about 0.9%, about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, or about 10%. In certain embodiments, the concentration of poloxamer in physiological saline is about 2%. In certain embodiments, the poloxamer is poloxamer 188. In certain embodiments, the compound is the compound of formula (Ia) or a pharmaceutically acceptable salt thereof. In certain embodiments, the compound is the compound of formula (Ia). In certain embodiments, the compound is the sodium salt of the compound of formula (Ia). In certain embodiments, the compound is the compound of formula (Ib) or a pharmaceutically acceptable salt thereof. In certain embodiments, the compound is the compound of formula (Ib).

[0194] In some embodiments, a suspension is provided comprising poloxamer and mannitol containing a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof. In some embodiments, the concentration of poloxamer in mannitol is about 0.1% to about 20%. In some embodiments, the concentration of poloxamer in mannitol is about 0.1% to about 10%. In some embodiments, the concentration of poloxamer in mannitol is about 0.1%, about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, about 0.9%, about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, or about 10%. In certain embodiments, the concentration of poloxamer in mannitol is about 2%. In certain embodiments, the poloxamer is poloxamer 188. In certain embodiments, the compound is the compound of formula (Ia) or a pharmaceutically acceptable salt thereof. In certain embodiments, the compound is the compound of formula (Ia). In certain embodiments, the compound is the sodium salt of the compound of formula (Ia). In certain embodiments, the compound is the compound of formula (Ib) or a pharmaceutically acceptable salt thereof. In certain embodiments, the compound is the compound of formula (Ib).

[0195] In certain embodiments, the composition is formulated as a solid dosage form. In some embodiments, the solid dosage form is a solid injectable dosage form, such as a solid depot form.

[0196] In certain embodiments, the active ingredient (e.g., a compound of formula (Ia) or formula (Ib)) exists as a free acid. In certain embodiments, the active ingredient (e.g., a compound of formula (Ia) or formula (Ib)) exists as a sodium salt. In some embodiments, the active ingredient is a compound of formula (Ia). In some embodiments, the active ingredient is a compound of formula (Ib).

[0197] In certain embodiments, the pharmaceutical composition is a parenteral formulation. In certain embodiments, the formulation is administered subcutaneously to the target (e.g., a human patient) that requires it. In certain embodiments, The drug is administered intramuscularly to the person who needs it.

[0198] In certain embodiments, the parenteral formulation comprises N-methyl-2-pyrrolidone (NMP). In certain embodiments, the parenteral formulation is essentially made from N-methyl-2-pyrrolidone. In certain embodiments, the parenteral formulation comprises dimethyl sulfoxide (DMSO). In some embodiments, the parenteral formulation comprises polyethylene glycol (PEG) or glycoflore. In some embodiments, the solution comprises PEG200, ethanol, and water. In some embodiments, the solution comprises PEG300 and water. In some embodiments, the solution comprises poloxamer in physiological saline. In some embodiments, the solution comprises 2% poloxamer 188 in normal physiological saline.

[0199] In certain embodiments, the parenteral formulation comprises a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, and water. In certain embodiments, the parenteral formulation comprises a compound of formula (Ia), or a pharmaceutically acceptable salt thereof, and water. In certain embodiments, the parenteral formulation comprises a compound of formula (Ib), or a pharmaceutically acceptable salt thereof, and water. In certain embodiments, the parenteral formulation further comprises an alcohol. In certain embodiments, the alcohol is ethanol. In certain embodiments, the parenteral formulation further comprises polyethylene glycol. In certain embodiments, the polyethylene glycol has an average molecular weight of about 200 g / mol (e.g., polyethylene glycol 200). In certain embodiments, the parenteral formulation further comprises an inorganic base. In certain embodiments, the inorganic base is sodium hydroxide (NaOH). In certain embodiments, the inorganic base is sodium ethoxide (NaOEt). In certain embodiments, the formulation contains about 0.1 molar equivalents to about 1.5 molar equivalents of the inorganic base. In certain embodiments, the formulation contains about 0.5 molar equivalents to about 1.5 molar equivalents of inorganic base. In certain embodiments, the formulation contains about 0.75 molar equivalents to about 1.2 molar equivalents of inorganic base. In certain embodiments, the formulation contains about 1.0 molar equivalent of inorganic base. In certain embodiments, the formulation contains about 1.2 molar equivalents of inorganic base. In some embodiments, the inorganic base is NaOH or NaOEt.

[0200] In certain embodiments, the parenteral formulation comprises the compound of formula (Ia) or a pharmaceutically acceptable salt thereof, water, and polyethylene glycol PEG300. In certain embodiments, the parenteral formulation comprises the compound of formula (Ib) or a pharmaceutically acceptable salt thereof, water, and polyethylene glycol PEG300.

[0201] In certain embodiments, the parenteral formulation comprises the compound of formula (Ia) or a pharmaceutically acceptable salt thereof, water, polyethylene glycol PEG300 (polyethylene glycol with an average molecular weight of 300 g / mol), and NaOH. In certain embodiments, the parenteral formulation comprises the compound of formula (Ia) or a pharmaceutically acceptable salt thereof, water, polyethylene glycol (PEG) 300, and NaOEt. In certain embodiments, the formulation contains about 0.1 to about 1.5 molar equivalents of NaOH or NaOEt. In certain embodiments, the formulation contains about 0.5 to about 1.5 molar equivalents of NaOH or NaOEt. In certain embodiments, the formulation contains about 0.75 to about 1.2 molar equivalents of NaOH or NaOEt. In certain embodiments, the formulation contains about 1.0 molar equivalent of NaOH or NaOEt. In certain embodiments, the formulation contains about 1.2 molar equivalents of NaOH or NaOEt.

[0202] In certain embodiments, the parenteral formulation is a solution formulation comprising a mixture of ethanol, water, and polyethylene glycol. In certain embodiments, the parenteral formulation is a solution formulation comprising a mixture of ethanol, water, and PEG200. In certain embodiments, the solution formulation comprises about 5% to about 20% ethanol, about 5% to about 20% water, and about 60% to about 90% PEG200. In certain embodiments, the solution formulation comprises about 10% to about 15% ethanol, about 10% to about 15% water, and about 70% to about 80% PEG200. In certain embodiments The solution formulation contains about 10% ethanol, about 12% water, and about 78% PEG200. In certain embodiments, the solution formulation further contains an inorganic base. In certain embodiments, the solution formulation contains about 10% ethanol, about 13% water, and about 77% PEG200. In certain embodiments, the solution formulation further contains an inorganic base. In certain embodiments, the formulation contains about 0.1 to about 1.5 molar equivalents of inorganic base. In certain embodiments, the formulation contains about 0.5 to about 1.5 molar equivalents of inorganic base. In certain embodiments, the formulation contains about 1.0 to about 1.2 molar equivalents of inorganic base. In certain embodiments, the formulation contains about 1.2 molar equivalents of inorganic base. In certain embodiments, the inorganic base is sodium hydroxide or sodium ethoxide. In certain embodiments, the inorganic base is sodium hydroxide.

[0203] In certain embodiments, the parenteral formulation is a solution formulation comprising a mixture of water and polyethylene glycol. In certain embodiments, the parenteral formulation is a solution formulation comprising a mixture of water and PEG300. In certain embodiments, the solution formulation comprises about 5% w / w to about 25% w / w of water and about 75% w / w to about 95% w / w of PEG300. In some embodiments, the solution formulation further comprises an inorganic base. In certain embodiments, the formulation comprises about 0.1 molar equivalents to about 1.5 molar equivalents of the inorganic base. In certain embodiments, the formulation comprises about 0.5 molar equivalents to about 1.5 molar equivalents of the inorganic base. In certain embodiments, the formulation comprises about 0.75 molar equivalents to about 1.2 molar equivalents of the inorganic base. In certain embodiments, the formulation comprises about 1.0 molar equivalent of the inorganic base. In certain embodiments, the formulation comprises about 1.2 molar equivalents of the inorganic base. In certain embodiments, the inorganic base is sodium hydroxide or sodium ethoxide. In certain embodiments, the inorganic base is sodium hydroxide.

[0204] In some embodiments, the solution comprises a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, PEG300, sodium hydroxide, and water. In some embodiments, the solution comprises a compound of formula (Ia) or a pharmaceutically acceptable salt thereof, PEG300, sodium hydroxide, and water. In some embodiments, the solution comprises a compound of formula (Ib), or a pharmaceutically acceptable salt thereof, PEG300, sodium hydroxide, and water. In some embodiments, the solution comprises a sodium salt of the compound of formula (Ia), PEG300, sodium hydroxide, and water. In some embodiments, the solution comprises a compound of formula (Ib), PEG300, sodium hydroxide, and water.

[0205] In some embodiments, the solution comprises the compound of formula (Ia), PEG300, sodium hydroxide, and water. In some embodiments, the concentration of the compound of formula (Ia) in the solution comprising the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 50 mg / mL to about 500 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in the solution comprising the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 50 mg / mL to about 400 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in the solution comprising the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 50 mg / mL to about 300 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in the solution comprising the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 75 mg / mL to about 300 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 50 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 75 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 100 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 125 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 125 mg / mL. The concentration of the compound of formula (Ia) in a solution containing PEG300, sodium hydroxide, and water is approximately 150 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is approximately 175 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is approximately 200 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is approximately 225 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is approximately 250 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is approximately 275 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is approximately 300 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is approximately 325 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is approximately 350 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is approximately 375 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is approximately 400 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is approximately 425 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is approximately 450 mg / mL.In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is approximately 475 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is approximately 500 mg / mL.

[0206] In some embodiments, the amount of water in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 10 w / w% to about 40 w / w%. In some embodiments, the amount of water in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 15 w / w% to about 35 w / w%. In some embodiments, the amount of water in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 20 w / w% to about 30 w / w%. In some embodiments, the amount of water in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 21 w / w% to about 29 w / w%. In some embodiments, the amount of water in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 23.2 w / w% to about 27.9 w / w%. In some embodiments, the amount of water in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 23.2 w / w% to about 27.92 w / w%. In some embodiments, the amount of water in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 22.0 w / w%, about 22.1 w / w%, about 22.2 w / w%, about 22.3 w / w%, about 22.4 w / w%, about 22.5 w / w%, about 22.6 w / w%, about 22.7 w / w%, about 22.8 w / w%, about 22.9 w / w%, about 23.0 w / w%, about 23.1 w / w%, about 23.2 w / w%, about 23.3 w / w%, and about 23.4 w / w%, approximately 23.5w / w%, approximately 23.6w / w%, approximately 23.7w / w%, approximately 23.8w / w%, approximately 23.9w / w%, approximately 24.0w / w%, approximately 24.1w / w%, approximately 24.2w / w%, approximately 24.3w / w%, approximately 24.4w / w%, approximately 24.5w / w%, approximately 24.6w / w%, approximately 24.7w / w%, approximately 24.8w / w%, approximately 24.9w / w%, approximately 25.0w / w%, approximately 25.1w / w%, approximately 25.2w / w%, approximately 25.3w / w%, approximately 25.4 w / w%, approximately 25.5 w / w%, approximately 25.6 w / w%, approximately 25.7 w / w%, approximately 25.8 w / w%, approximately 25.9 w / w%, approximately 26.0 w / w%, approximately 26.1 w / w%, approximately 26.2 w / w%, approximately 26.3 w / w%, approximately 26.4 w / w%, approximately 26.5 w / w%, approximately 26.6 w / w%, approximately 26.7 w / w%, approximately 26.8 w / w%, approximately 26.9 w / w%, approximately 27.0 w / w%, approximately 27.1 w / w%, approximately 27.2 w / w%, The amounts are approximately 27.3 w / w%, 27.4 w / w%, 27.5 w / w%, 27.6 w / w%, 27.7 w / w%, 27.8 w / w%, 27.9 w / w%, 28.0 w / w%, 28.1 w / w%, 28.2 w / w%, 28.3 w / w%, 28.4 w / w%, 28.5 w / w%, 28.6 w / w%, 28.7 w / w%, 28.8 w / w%, 28.9 w / w%, or 29.0 w / w%. In some embodiments, the amount of water in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is approximately 23.2 w / w%. In some embodiments, the amount of water in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 27.9 w / w%. In some embodiments, the amount of water in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 27.92 w / w%.

[0207] In some embodiments, the amount of PEG300 in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 35 w / w% to about 75 w / w%. In some embodiments, the amount of PEG300 in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 45 w / w% to about 65 w / w%. In some embodiments, the amount of PEG300 in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 48 w / w% to about 60 w / w%. In some embodiments, the amount of PEG300 in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 49 w / w% to about 59 w / w%. In some embodiments, the amount of PEG300 in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 50.0 w / w% to about 58.0 w / w%. In some embodiments, the amount of PEG300 in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 50.0 w / w% to about 58.04 w / w%. In some embodiments, the amount of PEG300 in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 45 w / w%, about 46 w / w%, about 47 w / w%, about 48 w / w%, about 49 w / w%, about 50 w / w%, about 51 w / w%, about 52 w / w%, about 53 w / w%, about 54 w / w%, about 55 w / w%, about 56 w / w%, about 57 w / w%, about 58 w / w%, about 59 w / w%, about 60 w / w%, about 61 w / w%, about 62 w / w%, about 63 w / w%, about 64 w / w%, or about 65 w / w%. In some embodiments, the amount of PEG300 in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 50.0 w / w%. In some embodiments, the amount of PEG300 in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 58.0 w / w%. In some embodiments, the amount of PEG300 in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 58.04 w / w%.

[0208] In some embodiments, the amount of compound (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 5 w / w% to about 35 w / w%. In some embodiments, the amount of compound (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 10 w / w% to about 30 w / w%. In some embodiments, the amount of compound (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 11 w / w% to about 28 w / w%. In some embodiments, the amount of compound (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 13 w / w% to about 27 w / w%. In some embodiments, the amount of compound (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is approximately 13.5 w / w% to approximately 25.7 w / w%. In some embodiments, the amount of compound (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is approximately 13.47 w / w% to approximately 25.7 w / w%. In some embodiments, the amount of compound (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is approximately 13.0 w / w%, approximately 13.1 w / w%, approximately 13.2 w / w%, approximately 13.3 w / w%, approximately 13.4 w / w%, approximately 13.5 w / w%, approximately 13.6 w / w%, approximately 13.7 w / w%, approximately 13.8 w / w%, approximately 13.9 w / w%, approximately 14.0 w / w%, approximately 14.1 w / w%, approximately 14.2 w / w%, approximately 14.3 w / w%, approximately 14.4 w / w%, approximately 14.5 w / w%, and approximately 14.6 w / w%. w / w%, approximately 14.7 w / w%, approximately 14.8 w / w%, approximately 14.9 w / w%, approximately 15.0 w / w%, approximately 15.1 w / w%, approximately 15.2 w / w%, approximately 15.3 w / w%, approximately 15.4 w / w%, approximately 15.5 w / w%, approximately 15.6 w / w%, approximately 15.7 w / w%, approximately 15.8 w / w%, approximately 15.9 w / w%, approximately 16.0 w / w%, approximately 16.1 w / w%, approximately 16.2 w / w%, approximately 16.3 w / w%, approximately 16.4 w / w%, approximately 16.5 w / w%, approximately 16.6 w / w%, approximately 16.7 w / w%, approximately 16.8 w / w%, approximately 16.9w / w%, about 17.0w / w%, about 17.1w / w%, about 17.2w / w%, about 17.3w / w%, about 17.4w / w%, about 17.5w / w%, about 17.6w / w%, about 17.7w / w%, about 17.8w / w%, about 17.9w / w%, about 18. 0w / w%, approximately 18.1w / w%, approximately 18.2w / w%, approximately 18.3w / w%, approximately 18.4w / w%, approximately 18.5w / w%, approximately 18.6w / w%, approximately 18.7w / w%, approximately 18.8w / w%, approximately 18.9w / w%, approximately 19.0w / w%, approximately 19.1w / w%, approximately 19.2 w / w%, approximately 19.3 w / w%, approximately 19.4 w / w%, approximately 19.5 w / w%, approximately 19.6 w / w%, approximately 19.7 w / w%, approximately 19.8 w / w%, approximately 19.9 w / w%, approximately 20.0 w / w%, approximately 21.1 w / w%, approximately 21.2 w / w%, approximately 21.3 w / w%, approximately 21.4 w / w%, approximately 21.5 w / w%, approximately 21.6 w / w%, approximately 21.7 w / w%, approximately 21.8 w / w%, approximately 21.9 w / w%, approximately 22.0 w / w%, approximately 22.1 w / w%, approximately 22.2 w / w%, approximately 22.3 w / w%, approximately 22.4 w / w%, approximately 22.5 w / w%, approximately 22.6 w / w%, approximately 22.7 w / w%, approximately 22.8 w / w%, approximately 22.9 w / w%, approximately 23.0 w / w%, approximately 23.1 w / w%, approximately 23.2 w / w%, approximately 23.3 w / w%, approximately 23.4 w / w%, approximately 23.5 w / w%, approximately 23.6 w / w%, approximately 23.7 w / w%, approximately 23.8 w / w%, approximately 23.9 w / w%, approximately 24.0 w / w%, approximately 24.1 w / w%, approximately 24.2 w / w%, approximately 24.3 w / w%, approximately 24.4 w / w%, approximately 24.5 w / w%, approximately 24.6 w / w%, approximately 24.7 w / w%, approximately 24.8 w / w%, approximately 24.9 w / w%, approximately 25.0 w / w%, approximately 25.1 w / w%, approximately 25.2 w / w%, approximately 25.3 w / w%, approximately 25.4 w / w%, approximately 25.5 w / w%, approximately 25.6 w / w%, approximately 25.7 w / w% Approximately 25.8 w / w%, approximately 25.9 w / w%, approximately 26.0 w / w%, approximately 26.1 w / w%, approximately 26.2 w / w%, approximately 26.3 w / w%, approximately 26.4 w / w%, approximately 26.5 w / w%, approximately 26.6 w / w%, approximately 26.7 w / w%, approximately 26.8 w / w%, approximately 26.9 w / w%, approximately 27.0 w / w%, approximately 27.1 w / w%, approximately 27.2 w / w%, approximately 27.3 w / w%, approximately 27.4 w / The amounts are approximately w%, 27.5 w / w%, 27.6 w / w%, 27.7 w / w%, 27.8 w / w%, 27.9 w / w%, 28.0 w / w%, 28.1 w / w%, 28.2 w / w%, 28.3 w / w%, 28.4 w / w%, 28.5 w / w%, 28.6 w / w%, 28.7 w / w%, 28.8 w / w%, 28.9 w / w%, or 29.0 w / w%. In some embodiments, the amount of compound (Ia) in a solution containing compound (Ia), PEG300, sodium hydroxide, and water is approximately 13.47 w / w%. In some embodiments, the amount of compound (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is approximately 13.5 w / w%. In some embodiments, the amount of compound (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is approximately 25.7 w / w%.

[0209] In some embodiments, the compound of formula (Ia), PEG300, sodium hydroxide, and The amount of sodium hydroxide in a solution containing water is about 0.05 w / w% to about 2 w / w%. In some embodiments, the amount of sodium hydroxide in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 0.1 w / w% to about 1.5 w / w%. In some embodiments, the amount of sodium hydroxide in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 0.3 w / w% to about 1.3 w / w%. In some embodiments, the amount of sodium hydroxide in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 0.5 w / w% to about 1.2 w / w%. In some embodiments, the amount of sodium hydroxide in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 0.6 w / w% to about 1.1 w / w%. In some embodiments, the amount of sodium hydroxide in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 0.58 w / w% to about 1.1 w / w%. In some embodiments, the amount of sodium hydroxide in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 0.1 w / w%, about 0.2 w / w%, about 0.3 w / w%, about 0.4 w / w%, about 0.5 w / w%, about 0.5 w / w%, about 1.6 w / w%, about 0.7 w / w%, about 0.8 w / w%, about 0.9 w / w%, about 1.0 w / w%, about 1.1 w / w%, about 1.2 w / w%, about 1.3 w / w%, about 1.4 w / w%, about 1.5 w / w%, about 1.6 w / w%, about 1.7 w / w%, about 1.8 w / w%, about 1.9 w / w%, or about 2.0 w / w%. In some embodiments, the amount of sodium hydroxide in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 0.58 w / w%. In some embodiments, the amount of sodium hydroxide in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 0.6 w / w%. In some embodiments, the amount of sodium hydroxide in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water is about 1.1 w / w%.In some embodiments, the solution contains about 10 w / w% to about 40 w / w% water, about 35 w / w% to about 75 w / w% PEG300, about 5 w / w% to about 35 w / w% of the compound of formula (Ia), and about 0.05 w / w% to about 2 w / w% sodium hydroxide. In some embodiments, the solution contains about 15 w / w% to about 35 w / w% water, about 45 w / w% to about 65 w / w% PEG300, about 10 w / w% to about 30 w / w% of the compound of formula (Ia), and about 0.1 w / w% to about 1.5 w / w% sodium hydroxide. In some embodiments, the solution contains about 20 w / w% to about 30 w / w% water, about 48 w / w% to about 60 w / w% PEG300, about 11 w / w% to about 28 w / w% of the compound of formula (Ia), and about 0.3 w / w% to about 1.3 w / w% sodium hydroxide. In some embodiments, the solution contains about 21 w / w% to about 29 w / w% water, about 49 w / w% to about 59 w / w% PEG300, about 13 w / w% to about 27 w / w% of the compound of formula (Ia), and about 0.5 w / w% to about 1.2 w / w% sodium hydroxide. In some embodiments, the solution contains about 23.2 w / w% to about 27.9 w / w% water, about 50 w / w% to about 58 w / w% PEG300, about 13.5 w / w% to about 25.7 w / w% of the compound of formula (Ia), and about 0.6 w / w% to about 1.1 w / w% sodium hydroxide. In some embodiments, the solution contains about 23.2 w / w% to about 27.92 w / w% water, about 50.0 w / w% to about 58.04 w / w% PEG300, about 13.47 w / w% to about 25.7 w / w% of the compound of formula (Ia), and about 0.58 w / w% to about 1.1 w / w% sodium hydroxide. In some embodiments, the solution contains about 27.9 w / w% water, about 58 w / w% PEG300, about 13.5 w / w% of the compound of formula (Ia), and about 0.6 w / w% sodium hydroxide. In some embodiments, the solution contains about 27.92 w / w% water, about 58.04 w / w% PEG300, about 13.47 w / w% of the compound of formula (Ia), and about 0.58 w / w% sodium hydroxide. In some embodiments, the solution contains about 23.2 w / w% water, about 50.0 w / w% PEG300, about 25.7 w / w% of the compound of formula (Ia), and about 1.1 w / w% sodium hydroxide.

[0210] In some embodiments, the compound of formula (Ia) is PEG300 In the presence of sodium hydroxide in a solution containing sodium hydroxide and water, the compound of formula (Ia) is ionized in situ to its sodium salt. Thus, in some embodiments, the compound of formula (Ia) exists as the sodium salt of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, and water.

[0211] In some embodiments, the pharmaceutical composition comprises a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, poloxamer, and a pharmaceutically acceptable excipient. In some embodiments, the pharmaceutical composition comprises a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, poloxamer 188, and a pharmaceutically acceptable excipient. In some embodiments, the pharmaceutical composition is a solution comprising a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, poloxamer, and a pharmaceutically acceptable excipient. In some embodiments, the pharmaceutical composition is a solution comprising a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, poloxamer 188, and a pharmaceutically acceptable excipient.

[0212] In some embodiments, the solution comprises a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, PEG300, sodium hydroxide, poloxamer 188, and water. In some embodiments, the solution comprises a compound of formula (Ia) or a pharmaceutically acceptable salt thereof, PEG300, sodium hydroxide, poloxamer 188, and water. In some embodiments, the solution comprises a compound of formula (Ib), or a pharmaceutically acceptable salt thereof, PEG300, sodium hydroxide, poloxamer 188, and water. In some embodiments, the solution comprises a sodium salt of the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water.

[0213] In some embodiments, the solution contains the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water. In some embodiments, the concentration of the compound of formula (Ia) in the solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 50 mg / mL to about 500 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in the solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 50 mg / mL to about 400 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in the solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 50 mg / mL to about 300 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 75 mg / mL to about 300 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 50 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 75 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 100 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 125 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 150 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 175 mg / mL. In some embodiments, the solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 175 mg / mL.The concentration of the compound of formula (Ia) in the given solution is approximately 200 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is approximately 225 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is approximately 250 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is approximately 275 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is approximately 300 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is approximately 325 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is approximately 350 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is approximately 375 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is approximately 400 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is approximately 425 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is approximately 450 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is approximately 475 mg / mL.In some embodiments, the concentration of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is approximately 500 mg / mL.

[0214] In some embodiments, the amount of water in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 10 w / w% to about 45 w / w%. In some embodiments, the amount of water in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 15 w / w% to about 35 w / w%. In some embodiments, the amount of water in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 20 w / w% to about 35 w / w%. In some embodiments, the amount of water in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 20 w / w% to about 31 w / w%. In some embodiments, the amount of water in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 22 w / w% to about 30.1 w / w%. In some embodiments, the amount of water in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 21.97 w / w% to about 30.07 w / w%. In some embodiments, the amount of water in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is approximately 19.0 w / w%, approximately 19.1 w / w%, approximately 19.2 w / w%, approximately 19.3 w / w%, approximately 19.4 w / w%, approximately 19.5 w / w%, approximately 19.6 w / w%, approximately 19.7 w / w%, approximately 19.8 w / w%, approximately 19.9 w / w%, approximately 20.0 w / w%, approximately 20.1 w / w%, and approximately 20.2 w / w. %, approximately 20.3 w / w%, approximately 20.4 w / w%, approximately 20.5 w / w%, approximately 20.6 w / w%, approximately 20.7 w / w%, approximately 20.8 w / w%, approximately 20.9 w / w%, approximately 21.0 w / w%, approximately 21.1 w / w%, approximately 21.2 w / w%, approximately 21.3 w / w%, approximately 21.4 w / w%, approximately 21.5 w / w%, approximately 21.6 w / w%, approximately 21.7 w / w%, approximately 21.8 w / w%, approximately 21.9 w / w%, approximately 22.0 w / w%, approximately 22.1 w / w%, Approximately 22.2 w / w%, 22.3 w / w%, 22.4 w / w%, 22.5 w / w%, 22.6 w / w%, 22.7 w / w%, 22.8 w / w%, 22.9 w / w%, 23.0 w / w%, 23.1 w / w%, 23.2 w / w%, 23.3 w / w%, and 23. 4 w / w%, approximately 23.5 w / w%, approximately 23.6 w / w%, approximately 23.7 w / w%, approximately 23.8 w / w%, approximately 23.9 w / w%, approximately 24.0 w / w%, approximately 24.1 w / w%, approximately 24.2 w / w%, approximately 24.3 w / w%, approximately 24.4 w / w%, approximately 24.5 w / w%, approximately 24.6 w / w %, approximately 24.7 w / w%, approximately 24.8 w / w%, approximately 24.9 w / w%, approximately 25.0 w / w%, approximately 25.1 w / w%, approximately 25.2 w / w%, approximately 25.3 w / w%, approximately 25.4 w / w%, approximately 25.5 w / w%, approximately 25.6 w / w%, approximately 25.7 w / w%, approximately 25.8 w / w%, approximately 2 5.9w / w%, approx. 26.0w / w%, approx. 26.1w / w%, approx. 26.2w / w%, approx. 26.3w / w%, approx. 26.4w / w%, approx. 26. 5w / w%, approx. 26.6w / w%, approx. 26.7w / w%, approx. 26.8w / w%, approx. 26.9w / w%, approx. 27.0w / w%, approx. 27.1w / w%, approximately 27.2 w / w%, approximately 27.3 w / w%, approximately 27.4 w / w%, approximately 27.5 w / w%, approximately 27.6 w / w%, approximately 27.7 w / w%, approximately 27.8 w / w%, approximately 27.9 w / w%, approximately 28.0 w / w%, approximately 28.1 w / w%, approximately 28.2 w / w%, approximately 28.3 w / w%, approximately 28.4 w / w%, approximately 28.5 w / w%, approximately 28.6 w / w%, approximately 28.7 w / w%, approximately 28.8 w / w%, approximately 28.9 w / w%, approximately 29.0 w / w%, approximately 29.1 w / w%, approximately 29.2 w / w%, approximately 29.3 w / w%, approximately 29.4 w / w%, approximately 29.5 w / w%, approximately 29.6 w / w%, approximately 29.7 w / w%, approximately 29.8 w / w%, approximately 29.9 w / w%, approximately 30.0 w / w%, approximately 30.1 w / w%, approximately 30.2 w / w%, approximately 30.3 w / w%, approximately 30.4 w / w%, approximately 30.5 w / w%, approximately 30.6 w / w%, approximately 30.7 w / w%, approximately 30.8 w / w% , approx. 30.9w / w%, approx. 31.0w / w%, approx. 31.1w / w%, approx. 31.2w / w%, approx. 31.3w / w%, approx. 31.4w / w%, approx. 31.5w / w%, approx. 31.6w / w%, approx. 31.7w / w%, approx. 31.8w / w%, approx. 31.9w / w%, approx. 32.0w / w%, approx. 32.The amounts are 1 w / w%, approximately 32.2 w / w%, approximately 32.3 w / w%, approximately 32.4 w / w%, approximately 32.5 w / w%, approximately 32.6 w / w%, approximately 32.7 w / w%, approximately 32.8 w / w%, approximately 32.9 w / w%, or approximately 33.0 w / w%. In some embodiments, the amount of water in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is approximately 21.97 w / w%. In some embodiments, the amount of water in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is approximately 22 w / w%. In some embodiments, the amount of water in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is approximately 30.07 w / w%. In some embodiments, the amount of water in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is approximately 30.1 w / w%.

[0215] In some embodiments, the amount of PEG300 in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 30 w / w% to about 85 w / w%. In some embodiments, the amount of PEG300 in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 35 w / w% to about 75 w / w%. In some embodiments, the amount of PEG300 in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 40 w / w% to about 70 w / w%. In some embodiments, the amount of PEG300 in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 45 w / w% to about 68 w / w%. In some embodiments, the amount of PEG300 in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 47.1 w / w% to about 64.4 w / w%. In some embodiments, the amount of PEG300 in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 47.05 w / w% to about 64.41 w / w%. In some embodiments, the compound of formula (Ia), PEG300 The amount of PEG300 in a solution containing 0, sodium hydroxide, poloxamer 188, and water is approximately 40 w / w%, approximately 41 w / w%, approximately 42 w / w%, approximately 43 w / w%, approximately 44 w / w%, approximately 45 w / w%, approximately 46 w / w%, approximately 47 w / w%, approximately 48 w / w%, approximately 49 w / w%, approximately 50 w / w%, approximately 51 w / w%, approximately 52 w / w%, approximately The amounts are 53 w / w%, approximately 54 w / w%, approximately 55 w / w%, approximately 56 w / w%, approximately 57 w / w%, approximately 58 w / w%, approximately 59 w / w%, approximately 60 w / w%, approximately 61 w / w%, approximately 62 w / w%, approximately 63 w / w%, approximately 64 w / w%, approximately 65 w / w%, approximately 66 w / w%, approximately 67 w / w%, approximately 68 w / w%, approximately 69 w / w%, or approximately 70 w / w%. In some embodiments, the amount of PEG300 in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is approximately 47.05 w / w%. In some embodiments, the amount of PEG300 in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is approximately 47.1 w / w%. In some embodiments, the amount of PEG300 in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 64.4 w / w%. In some embodiments, the amount of PEG300 in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 64.41 w / w%.

[0216] In some embodiments, the amount of compound (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 0.5 w / w% to about 40 w / w%. In some embodiments, the amount of compound (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 1 w / w% to about 35 w / w%. In some embodiments, the amount of compound (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 1 w / w% to about 30 w / w%. In some embodiments, the amount of compound (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 3 w / w% to about 28 w / w%. In some embodiments, the amount of compound (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 4 w / w% to about 26 w / w%. In some embodiments, the amount of compound (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 4.6 w / w% to about 25.2 w / w%. In some embodiments, the amount of compound (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 4.57 w / w% to about 25.21 w / w%.In some embodiments, the amount of compound (Ia) in a solution containing compound (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is approximately 3.0 w / w%, approximately 3.1 w / w%, approximately 3.2 w / w%, approximately 3.3 w / w%, approximately 3.4 w / w%, approximately 3.5 w / w%, approximately 3.6 w / w%, approximately 3.7 w / w%, approximately 3.8 w / w%, approximately 3.9 w / w%, approximately 4.0 w / w%, and approximately 4.1 w / w%, approximately 4.2 w / w%, approximately 4.3 w / w%, approximately 4.4 w / w%, approximately 4.5 w / w%, approximately 4.6 w / w%, approximately 4.7 w / w%, approximately 4.8 w / w%, approximately 4.9 w / w%, approximately 5.0 w / w%, approximately 5.1 w / w%, approximately 5.2 w / w%, approximately 5.3 w / w%, approximately 5.4 w / w%, approximately 5.5 w / w%, approximately 5.6 w / w%, approximately 5.7 w / w%, approximately 5.8 w / w%, approximately 5.9 w / w%, approximately 6.0 w / w%, approximately 6.1 w / w%, approximately 6.2 w / w%, approximately 6.3 w / w%, approximately 6.4 w / w%, approximately 6.5 w / w%, approximately 6.6 w / w%, approximately 6.7 w / w%, approximately 6.8 w / w%, approximately 6.9 w / w%, approximately 7.0 w / w%, approximately 7.1 w / w%, approximately 7.2 w / w%, approximately 7.3 w / w%, approximately 7.4 w / w%, approximately 7.5 w / w%, approximately 7.6 w / w%, approximately 7.7 w / w%, approximately 7.8 w / w%, approximately 7.9w / w%, approximately 8.0w / w%, approximately 8.1w / w%, approximately 8.2w / w%, approximately 8.3w / w%, approximately 8.4w / w%, approximately 8.5w / w%, approximately 8.6w / w%, approximately 8.7w / w%, approximately 8.8w / w%, about 8.9w / w%, about 9.0w / w%, about 9.1w / w%, about 9.2w / w%, about 9.3w / w%, about 9.4w / w%, about 9.5w / w%, about 9.6w / w%, about 9.7w / w%, about. 9.8 w / w%, approximately 9.9 w / w%, approximately 10.0 w / w%, approximately 10.1 w / w%, approximately 10.2 w / w%, approximately 10.3 w / w%, approximately 10.4 w / w%, approximately 10.5 w / w%, approximately 10.6 w / w%, approximately 10.7 w / w%, approximately 10.8 w / w%, approximately 10.9 w / w%, approximately 11.0 w / w %, about 11.1w / w%, about 11.2w / w%, about 11.3w / w%, about 11.4w / w%, about 11.5w / w%, about 11.6w / w%, Approx. 11.7w / w%, approx. 11.8w / w%, approx. 11.9w / w%, approx. 12.0w / w%, approx. 12.1w / w%, approx. 12.2w / w%, approx. 12 0.3w / w%, approximately 12.4w / w%, approximately 12.5w / w%, approximately 12.6w / w%, approximately 12.7w / w%, approximately 12.8w / w%, approximately 12.9w / w%, approximately 13.0w / w%, approximately 13.1w / w%, approximately 13.2w / w%, approximately 13.3w / w%, approximately 13.4w / w%, approximately 13.5w / w %, approximately 13.6 w / w%, approximately 13.7 w / w%, approximately 13.8 w / w%, approximately 13.9 w / w%, approximately 14.0 w / w%, approximately 14.1 w / w%, approximately 14.2 w / w%, approximately 14.3 w / w%, approximately 14.4 w / w%, approximately 14.5 w / w%, approximately 14.6 w / w%, approximately 14.7 w / w%, approximately 14 0.8 w / w%, approximately 14.9 w / w%, approximately 15.0 w / w%, approximately 15.1 w / w%, approximately 15.2 w / w%, approximately 15.3 w / w%, approximately 15.4 w / w%, approximately 15.5 w / w%, approximately 15.6 w / w%, approximately 15.7 w / w%, approximately 15.8 w / w%, approximately 15.9 w / w%, approximately 16.0 w / w %, about 16.1w / w%, about 16.2w / w%, about 16.3w / w%, about 16.4w / w%, about 16.5w / w%, about 16.6w / w%, Approx. 16.7w / w%, approx. 16.8w / w%, approx. 16.9w / w%, approx. 17.0w / w%, approx. 17.1w / w%, approx. 17.2w / w%, approx. 17 0.3w / w%, approximately 17.4w / w%, approximately 17.5w / w%, approximately 17.6w / w%, approximately 17.7w / w%, approximately 17.8w / w%, approximately 17.9w / w%, approximately 18.0w / w%, approximately 18.1w / w%, approximately 18.2w / w%, approximately 18.3w / w%, approximately 18.4w / w%, approximately 18.5w / w %, approximately 18.6 w / w%, approximately 18.7 w / w%, approximately 18.8 w / w%, approximately 18.9 w / w%, approximately 19.0 w / w%, approximately 19.1 w / w%, approximately 19.2 w / w%, approximately 19.3 w / w%, approximately 19.4 w / w%, approximately 19.5 w / w%, approximately 19.6 w / w%, approximately 19.7 w / w%, approximately 19.8 w / w%, approximately 19.9 w / w%, approximately 20.0 w / w%, approximately 21.1 w / w%, approximately 21.2 w / w%, approximately 21.3 w / w%, approximately 21.4 w / w%, approximately 21.5 w / w%, approximately 21.6 w / w%, approximately 21.7 w / w%, approximately 21.8 w / w%, approximately 21.9 w / w%, approximately 22.0 w / w%, approximately 22.1 w / w%, approximately 22.2 w / w%, approximately 22.3 w / w%, approximately 22.4 w / w%, approximately 22.5 w / w%, approximately 22.6 w / w%, approximately 22.7 w / w%, approximately 22.8 w / w%, approximately 22.9 w / w%, approximately 23.0 w / w%, approximately 23.1 w / w%, approximately 23.2 w / w%, approximately 23.3 w / w%, approximately 23.4 w / w%, approximately 23.5 w / w%, approximately 23.6 w / w%, approximately 23.7 w / w%, approximately 23.8 w / w%, approximately 23.9 w / w%, approximately 24.0 w / w%, approximately 24.1 w / w%, approximately 24.2 w / w%, approximately 24.3 w / w%, approximately 24.4 w / w%, approximately 24.5 w / w%, approximately 24.6 w / w%, approximately 24.7 w / w%, approximately 24.8 w / w%, approximately 24.9 w / w% Approximately 25.0 w / w%, approximately 25.1 w / w%, approximately 25.2 w / w%, approximately 25.3 w / w%, approximately 25.4 w / w%, approximately 25.5 w / w%, approximately 25.6 w / w%, approximately 25.7 w / w%, approximately 25.8 w / w%, approximately 25.9 w / w%, approximately 26.0 w / w%, approximately 26.1 w / w%, approximately 26.2 w / w%, approximately 26.3 w / w%, approximately 26.4 w / w%, approximately 26.5 w / w%, approximately 26.6 w / w%, approximately 26.7 w / w%, approximately 26.8 w / w%, approximately 26.9 w / w%, approximately 27.0 w / w%, approximately 27.1w / w%, approximately 27.2w / w%, approximately 27.3w / w%, approximately 27.4w / w%, approximately 27.5w / w%, approximately 27.6w / w%, approximately 27.7w / w%, approximately 27.8w / w%, approximately 27.9w / w%, approximately 28.0w / w%, approximately 28.1w / w%, approximately 28.2w / w%, approximately 28.3w / w%, approximately 28.4w / w%, approximately 28.5w / w%, approximately 28.6w / w%, approximately 28.7w / w%, approximately 28.8w / w%, approximately 28.9w / w%, or approximately 29.0w / w%. In some embodiments, the amount of compound (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is approximately 4.57 w / w%. In some embodiments, the amount of compound (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is approximately 4.6 w / w%. In some embodiments, the amount of compound (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 25.2 w / w%. In some embodiments, the amount of compound (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 25.21 w / w%.

[0217] In some embodiments, the amount of sodium hydroxide in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 0.01 w / w% to about 3.0 w / w%. In some embodiments, the amount of sodium hydroxide in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 0.01 w / w% to about 2.0 w / w%. In some embodiments, the amount of sodium hydroxide in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 0.05 w / w% to about 1.5 w / w%. In some embodiments, the amount of sodium hydroxide in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 0.05 w / w% to about 1.2 w / w%. In some embodiments, the amount of sodium hydroxide in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 0.1 w / w% to about 1.1 w / w%. In some embodiments, the amount of sodium hydroxide in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 0.10 w / w% to about 1.08 w / w%. In some embodiments, the amount of sodium hydroxide in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 0.01 w / w%, about 0.02 w / w%, about 0.03 w / w%, about 0.04 w / w%, about 0.05 w / w%, about 0.06 w / w%, about 0.07 w / w%, about 0.08 w / w%, about 0.09 w / w%, about 0.1 w / w%, and about 0. The amounts are 2 w / w%, approximately 0.3 w / w%, approximately 0.4 w / w%, approximately 0.5 w / w%, approximately 0.6 w / w%, approximately 0.7 w / w%, approximately 0.8 w / w%, approximately 0.9 w / w%, approximately 1.0 w / w%, approximately 1.1 w / w%, approximately 1.2 w / w%, approximately 1.3 w / w%, approximately 1.4 w / w%, approximately 1.5 w / w%, approximately 1.6 w / w%, approximately 1.7 w / w%, approximately 1.8 w / w%, approximately 1.9 w / w%, or approximately 2.0 w / w%. In some embodiments, the amount of sodium hydroxide in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is approximately 0.1 w / w%.In some embodiments, the amount of sodium hydroxide in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 0.10 w / w%. In some embodiments, the amount of sodium hydroxide in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 1.08 w / w%. In some embodiments, the amount of sodium hydroxide in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 1.1 w / w%.

[0218] In some embodiments, the amount of poloxamer 188 in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 0.1 w / w% to about 10 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 0.3 w / w% to about 8 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 0.5 w / w% to about 7 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 0.6 w / w% to about 7 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 0.85 w / w% to about 4.69 w / w%. In some embodiments, the compound of formula (Ia), PE The amount of poloxamer 188 in a solution containing G300, sodium hydroxide, poloxamer 188, and water is about 0.9 w / w% to about 4.7 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 0.5 w / w%, about 0.6 w / w%, about 0.7 w / w%, about 0.8 w / w%, about 0.9 w / w%, about 1.0 w / w%, about 1.1 w / w%, about 1.2 w / w%, about 1.3 w / w%, about 1.4 w / w%, about 1.5 w / w%, approximately 1.6 w / w%, approximately 1.7 w / w%, approximately 1.8 w / w%, approximately 1.9 w / w%, approximately 2.0 w / w%, approximately 2.1 w / w%, approximately 2.2 w / w%, approximately 2.3 w / w%, approximately 2.4 w / w%, approximately 2.5 w / w%, approximately 2.6 w / w%, approximately 2.7 w / w%, approximately 2.8 w / w%, approximately 2.9 w / w%, approximately 3.0 w / w%, approximately 3.1 w / w%, approximately 3.2 w / w%, approximately 3.3 w / w%, approximately 3. 4 w / w%, approximately 3.5 w / w%, approximately 3.6 w / w%, approximately 3.7 w / w%, approximately 3.8 w / w%, approximately 3.9 w / w%, approximately 4.0 w / w%, approximately 4.1 w / w%, approximately 4.2 w / w%, approximately 4.3 w / w%, approximately 4.4 w / w%, approximately 4.5 w / w%, approximately 4.6 w / w%, approximately 4.7 w / w%, approximately 4.8 w / w%, approximately 4.9 w / w%, approximately 5.0 w / w%, approximately 5.1 w / w%, approximately 5.2 w / w% The amounts are approximately 5.3 w / w%, 5.4 w / w%, 5.5 w / w%, 5.6 w / w%, 5.7 w / w%, 5.8 w / w%, 5.9 w / w%, 6.0 w / w%, 6.1 w / w%, 6.2 w / w%, 6.3 w / w%, 6.4 w / w%, 6.5 w / w%, 6.6 w / w%, 6.7 w / w%, 6.8 w / w%, 6.9 w / w%, or 7.0 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is approximately 0.85 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 0.9 w / w%. In some embodiments, the amount of poloxamer 188 in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is about 4.69 w / w%.In some embodiments, the amount of poloxamer 188 in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water is approximately 4.7 w / w%.

[0219] In some embodiments, the solution contains about 10 w / w% to about 45 w / w% water, about 30 w / w% to about 85 w / w% PEG300, about 0.5 w / w% to about 40 w / w% of the compound of formula (Ia), about 0.01 w / w% to about 3.0 w / w% sodium hydroxide, and about 0.1 w / w% to about 10 w / w% poloxamer 188. In some embodiments, the solution contains about 15 w / w% to about 35 w / w% water, about 35 w / w% to about 75 w / w% PEG300, about 1 w / w% to about 35 w / w% of the compound of formula (Ia), about 0.01 w / w% to about 2.0 w / w% sodium hydroxide, and about 0.3 w / w% to about 8 w / w% poloxamer 188. In some embodiments, the solution contains about 20 w / w% to about 35 w / w% water, about 40 w / w% to about 70 w / w% PEG300, about 1 w / w% to about 30 w / w% of the compound of formula (Ia), about 0.05 w / w% to about 1.5 w / w% sodium hydroxide, and about 0.5 w / w% to about 7 w / w% poloxamer 188. In some embodiments, the solution contains about 20 w / w% to about 31 w / w% water, about 45 w / w% to about 68 w / w% PEG300, about 3 w / w% to about 28 w / w% of the compound of formula (Ia), about 0.05 w / w% to about 1.2 w / w% sodium hydroxide, and about 0.6 w / w% to about 7 w / w% poloxamer 188.

[0220] In some embodiments, the solution contains about 22 w / w% to about 30.1 w / w% water, about 47.1 w / w% to about 64.4 w / w% PEG300, about 4.6 w / w% to about 25.2 w / w% compound of formula (Ia), about 0.1 w / w% to about 1.1 w / w% sodium hydroxide, and about 0.9 w / w% to about 4.7 w / w% poloxamer 188. In some embodiments, the solution contains about 21.97 w / w% to about 30.07 w / w% water, about 47.05 w / w% to about 64.41 w / w% PEG300, and about 4.57 w / w% to about 25.21 w / The solution contains w% of the compound of formula (Ia), about 0.10 w / w% to about 1.08 w / w% of sodium hydroxide, and about 0.85 w / w% to about 4.69 w / w% of poloxamer 188. In some embodiments, the solution contains about 30.1 w / w% water, about 64.4 w / w% PEG300, about 4.6 w / w% of the compound of formula (Ia), about 0.1 w / w% of sodium hydroxide, and about 0.9 w / w% of poloxamer 188. In some embodiments, the solution contains about 30.07 w / w% water, about 64.41 w / w% PEG300, about 4.57 w / w% of the compound of formula (Ia), about 0.10 w / w% of sodium hydroxide, and about 0.85 w / w% of poloxamer 188. In some embodiments, the solution comprises about 22 w / w% water, about 47.1 w / w% PEG300, about 25.2 w / w% compound of formula (Ia), about 1.1 w / w% sodium hydroxide, and about 4.7 w / w% poloxamer 188. In some embodiments, the solution comprises about 21.97 w / w% water, about 47.05 w / w% PEG300, about 25.21 w / w% compound of formula (Ia), about 1.08 w / w% sodium hydroxide, and about 4.69 w / w% poloxamer 188.

[0221] In some embodiments, the compound of formula (Ia) is ionized in situ to the sodium salt of the compound of formula (Ia) in the presence of sodium hydroxide in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water. Thus, in some embodiments, the compound of formula (Ia) exists as the sodium salt of the compound of formula (Ia) in a solution containing the compound of formula (Ia), PEG300, sodium hydroxide, poloxamer 188, and water.

[0222] In some embodiments, the solution formulation contains about 50 mg / mL of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof. In some embodiments, the solution formulation contains about 75 mg / mL of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof. In some embodiments, the solution formulation contains about 125 mg / mL of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof. In some embodiments, the solution formulation contains about 175 mg / mL of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof. In some embodiments, the solution formulation contains about 225 mg / mL of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof. In some embodiments, the solution formulation contains about 250 mg / mL of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof. In some embodiments, the solution formulation contains about 275 mg / mL of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof. In some embodiments, the solution formulation contains about 325 mg / mL of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof. In some embodiments, the solution formulation contains about 350 mg / mL of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof. In some embodiments, the solution formulation contains about 375 mg / mL of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof.

[0223] In some embodiments, the solution formulation contains about 100 mg / mL of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof. In some embodiments, the solution formulation contains about 150 mg / mL of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof. In some embodiments, the solution formulation contains about 200 mg / mL of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof. In some embodiments, the solution formulation contains about 300 mg / mL of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof. In some embodiments, the solution formulation contains about 400 mg / mL of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof.

[0224] In some embodiments, the solution formulation is approximately 425 mg / mL of formula (Ia) or formula ( The formulation contains the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof. In some embodiments, the solution formulation contains about 450 mg / mL of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof. In some embodiments, the solution formulation contains about 475 mg / mL of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof. In some embodiments, the solution formulation contains about 500 mg / mL of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof.

[0225] In some embodiments, the PEG300 in the solutions disclosed herein can be replaced with an equal amount of PEG400 or PEG600. In some embodiments, the PEG300 in the solutions disclosed herein can be replaced with an equal amount of PEG400. In some embodiments, the PEG300 in the solutions disclosed herein can be replaced with an equal amount of PEG600.

[0226] In some embodiments, the molar ratio of sodium to the compound of formula (Ia) or formula (Ib) is about 0:1 to about 1.5:1. In some embodiments, the molar ratio of sodium to the compound of formula (Ia) is about 0:1 to about 1.5:1. In some embodiments, the molar ratio of sodium to the compound of formula (Ia) is about 0:1 to about 1.2:1. In some embodiments, the molar ratio of sodium to the compound of formula (Ia) is about 0:1. In some embodiments, the molar ratio of sodium to the compound of formula (Ia) is about 0.5:1. In some embodiments, the molar ratio of sodium to the compound of formula (Ia) is about 1:1. In some embodiments, the molar ratio of sodium to the compound of formula (Ia) is about 1.2:1.

[0227] In some embodiments, the solution is administered by subcutaneous injection. In some embodiments, the solution is administered by intramuscular injection.

[0228] In some embodiments of the methods disclosed herein, a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered subcutaneously at a concentration of about 309 mg / mL.

[0229] In some embodiments of the methods disclosed herein, a solution of the sodium salt of the compound of formula (Ia) is administered subcutaneously, and the solution comprises about 20 w / w% to about 30 w / w% water, about 48 w / w% to about 60 w / w% PEG300, and about 11 w / w% to about 28 w / w% of the sodium salt of the compound of formula (Ia).

[0230] In some embodiments of the methods disclosed herein, a solution of the sodium salt of the compound of formula (Ia) is administered subcutaneously, the solution comprising about 23.41 w / w% water, about 50.13 w / w% PEG300, and about 26.46 w / w% sodium salt of the compound of formula (Ia).

[0231] In some embodiments of the methods disclosed herein, a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered intramuscularly.

[0232] In some embodiments of the methods disclosed herein, the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, is administered intramuscularly at a concentration of about 400 mg / mL to about 500 mg / mL.

[0233] In certain embodiments, oral formulations are provided of a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, and at least one excipient. Excipients include ethanol, medium-chain triglycerides, vitamin E, d-α-tocopherol, polyethylene glycosides. Examples of suitable medium-chain triglycerides include MIGLYOL 1000 succinate (TPGS), glycerol monocaprylate, glycerin, and / or pharmaceutically acceptable oils. Examples of suitable medium-chain triglycerides include MIGLYOL 810, MIGLYOL 821, and MIGLYOL 840 are listed, but are not limited to. Examples of suitable pharmaceutically acceptable oils include, but are not limited to, sesame oil, castor oil, safflower oil, vegetable oil, and soybean oil. Oral formulations may contain any combination of one or more suitable excipients. The excipients incorporated together may be present in amounts of more than 65% by weight, more than 70% by weight, more than 80% by weight, more than 90% by weight, or more than 95% by weight of the total oral formulation.

[0234] In some embodiments, oral formulations of a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, and at least one excipient are prepared in hard capsules or soft capsules. In some embodiments, the hard capsules or soft capsules contain a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, and ethanol, propylene glycol, glycerin, d-α-tocopherol polyethylene glycol 1000 succinate (TPGS), polyoxyl 35 castor oil (e.g., Kolliphor® EL), glycerol monocaprylate (e.g., Capmul® MCM), PEG400 capryl / capric glyceride (e.g., Labrasol®). It comprises one or more excipients selected from the group consisting of (standard), PEG400, diethylene glycol monoethyl ether (e.g., Transcutol®), propylene glycol monocaprylate, type II (e.g., Capryol® 90), glyceryl monooleate, type 40 (e.g., Peceol®), medium-chain triglycerides (e.g., Miglyol® 812N), glyceryl monolinoleate (e.g., Maisine®), and polysorbate 80. In some embodiments, the hard capsule or soft capsule comprises a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, and one or more excipients selected from the group consisting of ethanol, medium-chain triglycerides (e.g., Miglyol® 812N), d-α-tocopherol polyethylene glycol 1000 succinate (TPGS), glycerol monocaprylocate (e.g., Capmul® MCM), PEG400 capryl / capric glyceride (e.g., Labrasol®), and PEG400.

[0235] In some embodiments, the hard capsule or soft capsule further comprises a capsule shell. In some embodiments, the capsule shell comprises one or more pharmaceutically acceptable excipients. In some embodiments, the one or more pharmaceutically acceptable excipients of the capsule shell are selected from the group consisting of gelatin shells, plasticizers, opacifiers, and colorants. Plasticizers, opacifiers, and colorants are known in the art. In some embodiments, the capsule shell comprises one or more pharmaceutically acceptable excipients selected from the group consisting of gelatin, glycerin, titanium dioxide, and iron oxide. In some embodiments, the iron oxide comprises iron oxide (yellow).

[0236] In some embodiments, oral formulations of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, are provided. In certain embodiments, the oral formulation comprises the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, and glycerol monocaprilocate. In certain embodiments, the oral formulation comprises the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, about 5% to about 20% ethanol, about 10% to about 30% vitamin E TPGS, and about 50% to about 85% MIGLYOL 812. In some embodiments, the oral formulation comprises the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, about 8% to about 15% ethanol, about 15% to about 25% vitamin E TPGS, and about 60% to about 77% MIGLYOL 812. In certain embodiments, the oral formulation comprises about 10% ethanol, about 20% vitamin E TPGS, and about 70% of a compound of formula (Ia) or formula (Ib) in MIGLYOL 812, or a pharmaceutically acceptable salt thereof. In certain embodiments, the oral formulation is prepared in hard gelatin capsules. In certain embodiments, the oral formulation is prepared in soft gelatin capsules.

[0237] In some embodiments, the hard or soft gelatin capsule contains a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable excipient. In some embodiments, the hard or soft gelatin capsule contains a compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, and a glycerol monocaprylocate. In some embodiments, the concentration of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, in the hard or soft gelatin capsule is about 10 mg / mL to about 500 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, in the hard or soft gelatin capsule is about 10 mg / mL to about 400 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) or formula (Ib), or its pharmaceutically acceptable salt, in the hard gelatin or soft gelatin capsule is about 50 mg / mL to about 300 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) or formula (Ib), or its pharmaceutically acceptable salt, in the hard gelatin or soft gelatin capsule is about 50 mg / mL to about 200 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) or formula (Ib), or its pharmaceutically acceptable salt, in the hard gelatin or soft gelatin capsule is about 50 mg / mL to about 100 mg / mL. In some embodiments, the concentrations of the compound of formula (Ia) or formula (Ib), or its pharmaceutically acceptable salt, in hard gelatin or soft gelatin capsules are approximately 10 mg / mL, approximately 15 mg / mL, approximately 20 mg / mL, approximately 25 mg / mL, approximately 30 mg / mL, approximately 30 mg / mL, approximately 40 mg / mL, approximately 45 mg / mL, approximately 50 mg / mL, approximately 55 mg / mL, approximately 60 mg / mL, approximately 65 mg / mL, approximately 70 mg / mL, and approximately 75 mg / mL, approximately 80mg / mL, approximately 85mg / mL, approximately 90mg / mL, approximately 95mg / mL, approximately 100mg / mL, approximately 105mg / mL, approximately 110mg / mL, approximately 115mg / mL, approximately 120mg / mL, approximately 125m g / mL, approximately 130 mg / mL, approximately 135 mg / mL, approximately 140 mg / mL, approximately 145 mg / mL, approximately 150 mg / mL, approximately 155 mg / mL, approximately 160 mg / mL, approximately 165 mg / mL, approximately 170 mg / mL,Approx. 175mg / mL, Approx. 180mg / mL, Approx. 185mg / mL, Approx. 190mg / mL, Approx. 195mg / mL, Approx. 200mg / mL, 205mg / mL, Approx. 210mg / mL, Approx. 215 mg / mL, approx. 220 mg / mL, approx. 225 mg / mL, approx. 230 mg / mL, approx. 235 mg / mL, approx. 240 mg / mL, approx. 245 mg / mL, approx. 250 mg / mL, approx. 255 mg / mL mL, approximately 260 mg / mL, approximately 265 mg / mL, approximately 270 mg / mL, approximately 275 mg / mL, approximately 280 mg / mL, approximately 285 mg / mL, approximately 290 mg / mL, approximately 295 mg / mL, Approx. 300mg / mL, approx. 305mg / mL, approx. 310mg / mL, approx. 315mg / mL, approx. 320mg / mL, approx. 325mg / mL, approx. 330mg / mL, approx. 335mg / mL, approx. 34 0mg / mL, approx. 345mg / mL, approx. 350mg / mL, approx. 355mg / mL, approx. 360mg / mL, approx. 365mg / mL, approx. 370mg / mL, approx. 375mg / mL, approx. 380mg / mL, approx. 385 mg / mL, approx. 390 mg / mL, approx. 395 mg / mL, approx. 400 mg / mL, approx. 405 mg / mL, approx. 410 mg / mL, approx. 415 mg / mL, approx. 420 mg / mL The concentrations are approximately 425 mg / mL, 430 mg / mL, 435 mg / mL, 440 mg / mL, 445 mg / mL, 450 mg / mL, 455 mg / mL, 460 mg / mL, 465 mg / mL, 470 mg / mL, 475 mg / mL, 480 mg / mL, 485 mg / mL, 490 mg / mL, 495 mg / mL, or 500 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, in hard gelatin or soft gelatin capsules is approximately 10 mg / mL. In some embodiments, hard gelatin, The concentration of the compound of formula (Ia) or formula (Ib), or its pharmaceutically acceptable salt, in hard gelatin or soft gelatin capsules is approximately 20 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) or formula (Ib), or its pharmaceutically acceptable salt, in hard gelatin or soft gelatin capsules is approximately 30 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) or formula (Ib), or its pharmaceutically acceptable salt, in hard gelatin or soft gelatin capsules is approximately 40 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) or formula (Ib), or its pharmaceutically acceptable salt, in hard gelatin or soft gelatin capsules is approximately 50 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) or formula (Ib), or its pharmaceutically acceptable salt, in hard gelatin or soft gelatin capsules is approximately 75 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) or formula (Ib), or its pharmaceutically acceptable salt, in a hard gelatin or soft gelatin capsule is about 100 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) or formula (Ib), or its pharmaceutically acceptable salt, in a hard gelatin or soft gelatin capsule is about 125 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) or formula (Ib), or its pharmaceutically acceptable salt, in a hard gelatin or soft gelatin capsule is about 150 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) or formula (Ib), or its pharmaceutically acceptable salt, in a hard gelatin or soft gelatin capsule is about 175 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) or formula (Ib), or its pharmaceutically acceptable salt, in a hard gelatin or soft gelatin capsule is about 200 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, in a hard gelatin or soft gelatin capsule is about 225 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) or formula (Ib), or a pharmaceutically acceptable salt thereof, in a hard gelatin or soft gelatin capsule is about 250 mg / mL.In some embodiments, the concentration of the compound of formula (Ia) or formula (Ib), or its pharmaceutically acceptable salt, in a hard gelatin or soft gelatin capsule is about 275 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) or formula (Ib), or its pharmaceutically acceptable salt, in a hard gelatin or soft gelatin capsule is about 300 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) or formula (Ib), or its pharmaceutically acceptable salt, in a hard gelatin or soft gelatin capsule is about 325 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) or formula (Ib), or its pharmaceutically acceptable salt, in a hard gelatin or soft gelatin capsule is about 350 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) or formula (Ib), or its pharmaceutically acceptable salt, in a hard gelatin or soft gelatin capsule is about 375 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) or formula (Ib), or its pharmaceutically acceptable salt, in a hard gelatin or soft gelatin capsule is about 400 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) or formula (Ib), or its pharmaceutically acceptable salt, in a hard gelatin or soft gelatin capsule is about 425 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) or formula (Ib), or its pharmaceutically acceptable salt, in a hard gelatin or soft gelatin capsule is about 450 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) or formula (Ib), or its pharmaceutically acceptable salt, in a hard gelatin or soft gelatin capsule is about 475 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) or formula (Ib), or its pharmaceutically acceptable salt, in a hard gelatin or soft gelatin capsule is about 500 mg / mL.

[0238] In some embodiments, the hard or soft gelatin capsule comprises a compound of formula (Ib), or a pharmaceutically acceptable salt thereof, and a glycerol monocaprilocate.

[0239] In some embodiments, hard gelatin or soft gelatin capsules are compound of formula (Ia). and glycerol monocapryloca plate. In some embodiments, the concentration of the compound of formula (Ia) in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocapryloca plate is about 10 mg / mL to about 500 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocapryloca plate is about 10 mg / mL to about 400 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocapryloca plate is about 50 mg / mL to about 300 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocapryloca plate is about 75 mg / mL to about 300 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocapryloca plate is about 50 mg / mL to about 200 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocapryloca plate is about 50 mg / mL to about 100 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocapryloca plate is about 10 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocapryloca plate is about 20 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocaprilocate is about 30 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocaprilocate is about 40 mg / mL.In some embodiments, the concentration of the compound of formula (Ia) in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocapryloca plate is about 50 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocapryloca plate is about 75 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocapryloca plate is about 100 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocapryloca plate is about 125 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocapryloca plate is about 150 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocapryloca plate is about 175 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocapryloca plate is about 200 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocapryloca plate is about 225 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocaprilocate is about 250 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocaprilocate is about 275 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocaprilocate is about 300 mg / mL.In some embodiments, the concentration of the compound of formula (Ia) in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocaprilocate is approximately 325 mg. The concentration is approximately 350 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocapryloca plate is approximately 350 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocapryloca plate is approximately 375 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocapryloca plate is approximately 400 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocapryloca plate is approximately 425 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocaprilocate is about 450 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocaprilocate is about 475 mg / mL. In some embodiments, the concentration of the compound of formula (Ia) in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocaprilocate is about 500 mg / mL.

[0240] In some embodiments, the amount of glycerol monocaprylocate in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocaprylocate is about 30 w / w% to about 85 w / w%. In some embodiments, the amount of glycerol monocaprylocate in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocaprylocate is about 40 w / w% to about 80 w / w%. In some embodiments, the amount of glycerol monocaprylocate in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocaprylocate is about 50 w / w% to about 80 w / w%. In some embodiments, the amount of glycerol monocaprylocate in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocaprylocate is about 60 w / w% to about 70 w / w%. In some embodiments, the amount of glycerol monocaprilocate in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocaprilocate is about 65.9 w / w%. In some embodiments, the amount of glycerol monocaprilocate in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocaprilocate is about 65.94 w / w%.

[0241] In some embodiments, the amount of the compound of formula (Ia) in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocaprylocate is about 1 w / w% to about 40 w / w%. In some embodiments, the amount of the compound of formula (Ia) in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocaprylocate is about 1 w / w% to about 35 w / w%. In some embodiments, the amount of the compound of formula (Ia) in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocaprylocate is about 2 w / w% to about 30 w / w%. In some embodiments, the amount of the compound of formula (Ia) in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocaprylocate is about 3 w / w% to about 28 w / w%. In some embodiments, the amount of the compound of formula (Ia) in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocaprilocate is about 3.4 w / w%. In some embodiments, the amount of the compound of formula (Ia) in a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocaprilocate is about 3.42 w / w%.

[0242] In some embodiments, a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocaprilocate further comprises a capsule shell. In some embodiments, the capsule shell contains one or more pharmaceutically acceptable excipients. In some embodiments, the one or more pharmaceutically acceptable excipients of the capsule shell are selected from the group consisting of gelatin shells, plasticizers, opacifiers, and colorants. In some embodiments, a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocapryloca plate further contains one or more pharmaceutically acceptable excipients selected from the group consisting of gelatin, glycerin, titanium dioxide, and iron oxide. In some embodiments, a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocapryloca plate further contains gelatin. In some embodiments, a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocapryloca plate further contains glycerin. In some embodiments, a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocapryloca plate further contains titanium dioxide. In some embodiments, a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocaprylocate further comprises iron oxide. In some embodiments, a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocaprylocate further comprises gelatin and glycerin. In some embodiments, a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocaprylocate further comprises gelatin, glycerin, and titanium dioxide. In some embodiments, a hard or soft gelatin capsule containing the compound of formula (Ia) and glycerol monocaprylocate further comprises gelatin, glycerin, titanium dioxide, and iron oxide. In some embodiments, the iron oxide in a hard or soft gelatin capsule containing the compound of formula (Ia), glycerol monocaprylocate, gelatin, glycerin, titanium dioxide, and iron oxide comprises iron oxide (yellow).

[0243] In some embodiments, the amount of gelatin in a hard or soft gelatin capsule containing the compound of formula (Ia), glycerol monocaprylocate, gelatin, glycerin, titanium dioxide, and iron oxide is about 10 w / w% to about 40 w / w%. In some embodiments, the amount of gelatin in a hard or soft gelatin capsule containing the compound of formula (Ia), glycerol monocaprylocate, gelatin, glycerin, titanium dioxide, and iron oxide is about 10 w / w% to about 30 w / w%. In some embodiments, the amount of gelatin in a hard or soft gelatin capsule containing the compound of formula (Ia), glycerol monocaprylocate, gelatin, glycerin, titanium dioxide, and iron oxide is about 15 w / w% to about 25 w / w%. In some embodiments, the amount of gelatin in a hard or soft gelatin capsule containing the compound of formula (Ia), glycerol monocaprylocate, gelatin, glycerin, titanium dioxide, and iron oxide is about 18 w / w% to about 22 w / w%. In some embodiments, the amount of gelatin in a hard or soft gelatin capsule containing the compound of formula (Ia), glycerol monocaprylocate, gelatin, glycerin, titanium dioxide, and iron oxide is about 19.6 w / w%. In some embodiments, the amount of gelatin in a hard or soft gelatin capsule containing the compound of formula (Ia), glycerol monocaprylocate, gelatin, glycerin, titanium dioxide, and iron oxide is about 19.60 w / w%.

[0244] In some embodiments, the amount of glycerin in a hard or soft gelatin capsule containing the compound of formula (Ia), glycerol monocaprilocate, gelatin, glycerin, titanium dioxide, and iron oxide is about 3 w / w% to about 25 w / w%. In some embodiments, the amount of glycerin in a hard or soft gelatin capsule containing the compound of formula (Ia), glycerol monocaprilocate, gelatin, glycerin, titanium dioxide, and iron oxide is about 5 w / w% to about 20 w / w%. In some embodiments, the amount of glycerin in a hard or soft gelatin capsule containing the compound of formula (Ia), glycerol monocaprilocate, gelatin, glycerin, titanium dioxide, and iron oxide is about 5 w / w% to about 15 w / w%. In some embodiments, the compound of formula (Ia), glycerol The amount of glycerin in a hard or soft gelatin capsule containing glycerol monocaprylocate, gelatin, glycerin, titanium dioxide, and iron oxide is approximately 8 w / w% to approximately 12 w / w%. In some embodiments, the amount of glycerin in a hard or soft gelatin capsule containing the compound of formula (Ia), glycerol monocaprylocate, gelatin, glycerin, titanium dioxide, and iron oxide is approximately 10.8 w / w%. In some embodiments, the amount of glycerin in a hard or soft gelatin capsule containing the compound of formula (Ia), glycerol monocaprylocate, gelatin, glycerin, titanium dioxide, and iron oxide is approximately 10.80 w / w%.

[0245] In some embodiments, the amount of titanium...

Claims

1. 20 w / w% to 30 w / w% water, 48 w / w% to 60 w / w% PEG300, and 11 w / w% to 28 w / w% of formula (Ia): 【Chemistry 1】 A solution comprising a sodium salt of a compound for use in a method for preventing HIV infection in a subject or reducing the risk of HIV infection in a subject, wherein the solution is administered subcutaneously to the subject once every six months.

2. The solution for use according to claim 1, wherein the sodium salt of the compound of formula (Ia) is administered subcutaneously at a concentration of about 309 mg / mL.

3. A solution for use according to Claim 1, wherein the sodium salt of the compound of formula (Ia) is administered in doses of 10 mg to 2000 mg, and optionally, the sodium salt of the compound of formula (Ia) is administered in doses of about 50 mg, about 100 mg, about 150 mg, about 200 mg, about 250 mg, about 300 mg, about 350 mg, about 400 mg, about 450 mg, about 500 mg, about 550 mg, about 600 mg, about 650 mg, about 700 mg, about 750 mg, about 800 mg, about 8 A solution for use, administered in doses of 50 mg, approximately 900 mg, approximately 950 mg, or approximately 1000 mg, approximately 1050 mg, approximately 1100 mg, approximately 1150 mg, approximately 1200 mg, approximately 1250 mg, approximately 1300 mg, approximately 1350 mg, approximately 1400 mg, approximately 1450 mg, approximately 1500 mg, approximately 1550 mg, approximately 1600 mg, approximately 1650 mg, approximately 1700 mg, approximately 1750 mg, approximately 1800 mg, approximately 1850 mg, approximately 1900 mg, approximately 1950 mg, or approximately 2000 mg.

4. The solution for use according to claim 1, wherein the solution is administered as monotherapy.

5. The solution for use according to claim 1, wherein the method comprises (i) pre-exposure prophylaxis (PrEP) or (ii) post-exposure prophylaxis (PEP), or (iii) pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP).

6. The solution for use according to claim 1, wherein the solution is administered to the subject before exposure to HIV.

7. The solution for use according to claim 1, comprising administering the solution to the subject after their final exposure to HIV.

8. The solution for use according to claim 7, wherein the solution is administered once every 1 hour to 14 days after the subject's last exposure to HIV, or once every 1 hour to 7 days after the subject's last exposure to HIV, or once every 1 hour to 72 hours after the subject's last exposure to HIV.

9. A solution for use according to claim 1, wherein the method is (i) administering the solution to the subject about seven days before their exposure to HIV; and (ii) Administer the solution once every six months during the HIV exposure period. This includes, if necessary, the solution administered in step (i) being in a different dose than the solution administered in step (ii). Solution for use.

10. The solution for use according to claim 1, wherein the reduction in the risk of HIV infection is at least about 75% compared to a subject to which the solution has not been administered.

11. The solution for use according to any one of claims 1 to 10, wherein the solution comprises about 23.41 w / w% water, about 50.13 w / w% PEG300, and about 26.46 w / w% sodium salt of the compound of formula (Ia).

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