26 results about "Once daily dosing" patented technology

Provided herein are oral dosage forms comprising a) a core tablet comprising (i) a drug layer comprising apremilast and hypromellose acetate succinate (HPMCAS) in an amorphous solid dispersion; and (ii) a swellable layer comprising one or more swellable polymers; and b) a coating layer disposed on the core tablet, wherein the oral dosage form surface comprises at least one drug release orifice. The disclosed oral dosage forms provide once-a-day dosing of apremilast and are suitable for treating diseases or disorders ameliorated by inhibiting phosphodiesterase subtype IV (PDE4).

The patent document discloses a dosage form featuring a unique combination of extended-release and immediate-release components of the active ingredient. This dosage form allows for high drug loading, enabling once-daily administration while providing a sustained window of effective treatment with reduced fluctuations in drug concentration. The document also discloses a method for treating neurological or psychiatric diseases or conditions in a subject.

The present disclosure provides GIP receptor agonist peptide compounds suitable for once per day dosing (QD), said peptide compounds having an activating action on GIP receptors and use of the GIP receptor agonist peptide as a medicament for the treatment and / or prevention of emesis, or a symptom or condition associated with emesis while having an improved profile.

A pharmaceutical composition includes about 100 mg to about 280 mg of troriluzole, a pharmaceutically acceptable salt thereof, a hydrate thereof, or a hydrate of the salt, wherein the pharmaceutical composition is in a once-a-day oral dosage form, which provides an AUC0-inf for riluzole of about 80% to about 125% of about 791 h•ng / mL to about 2330 h•ng / mL. A method of treating a disease or a condition in a patient in need thereof includes administering to the patient once daily the pharmaceutical composition.

To provide dosing regimens of GLP-1 analogs for the treatment of fat, obese, overweight, nonalcoholic fatty liver disease (NAFLD), and / or nonalcoholic steatohepatitis (NASH).SOLUTION: Administering to the subject a first effective amount of one or more first active ingredients selected from the group consisting of GLP-1 and GLP-1 analogs; A dosing regimen is provided, comprising: a first effective amount administered continuously, or intermittently at an interval between two consecutive administrations of six hours or less; and one or more second active ingredients selected from the group consisting of a second effective amount of GLP-I and a GLP-1 analog, administered to said subject once daily, twice daily, three times daily, or four times daily.SELECTED DRAWING: None

According to the pharmaceutical composition for treating glaucoma and intraocular hypertension provided by the invention, the stability of the pharmaceutical composition is obviously improved through a salt changing technology; the pharmaceutical composition is prepared from netasdil free alkali or a pharmaceutically acceptable salt thereof, timolol free alkali or a pharmaceutically acceptable salt thereof, and dorzolamide free alkali or a pharmaceutically acceptable salt thereof. The pharmaceutical composition has excellent stability when the pH value is 4.5-5.4. According to the present invention, the effective dose of the pharmaceutical composition is applied to the eyes of the patient requiring the intraocular pressure at the sleeping time or at the time close to the sleeping time once a day, such that the intraocular pressure can be efficiently and rapidly reduced so as to maintain the intraocular pressure in the physiological range for a long time, the side effect is small, and the patient compliance is high.

Pharmaceutical compositions of colchicine for once-a-day oral administration are provided. The formulations comprise a sustained-release component and an optional immediate-release component, the compositions of which can be selectively adjusted, respectively, to release the active ingredient along a pre-determined or desired release profile. Methods of treating or preventing cardiovascular disease and / or inflammatory disease in mammalian subjects comprising the administration of the novel formulations disclosed herein are also provided.

Provided herein are osmotic dosage forms containing deutetrabenazine for use in the treatment of, e.g., hyperkinetic movement disorders. When orally administered to a subject on a once-daily basis, the dosage forms provide a favorable pharmacokinetic profile for the active agent indicating treatment efficacy over an extended period of time.

The present disclosure provides a method of treating a neurodegenerative disease such as Alzheimer's disease in a subject. The method includes administering to the subject about 30 mg of AR1001 orally once daily, or a pharmaceutically acceptable salt thereof, and monitoring plasma phosphorylated tau 181 (pTau181) or phosphorylated tau 217 (pTau217) levels in the subject during treatment. The method may further include continuing AR1001 treatment if the subject's plasma pTau181 or pTau217 levels decrease during treatment. The subject may have mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease dementia. The method may also include assessing the subject's cognitive function using one or more standardized tests during treatment. AR1001 may be administered in a pharmaceutical composition in the form of a tablet or capsule.

The invention relates to a pharmaceutical dosage form filled with formulations for once-a-day oral administration of deferiprone and deferasirox. Both formulations are in form of coated pellets or coated minitablets. The invention is directed to the claimed pharmaceutical dosage form for use in the treatment of diseases which cause an overload of iron.

The present invention provides a topical pharmaceutical formulation comprising a combination of miconazole or a pharmaceutically acceptable salt thereof and domiphen bromide, a formulation vehicle and a viscosity modifier; wherein the ratio of w / w% miconazole (salt) to w / w% domiphen bromide is between 6 to 20 endpoints included and wherein the amount of viscosity modifier is sufficient to adjust the viscosity of the topical formulation to a value of 1000-4600 mPa.s measured at 25°C. The invention further provides use of said formulation in a treatment of vaginal Candida (biofilm) infections, wherein once daily use of 4.5-5.5 g of the formulation for a duration of 7 days performed better than a reference product and unexpectedly also performed better than a formulation with a double domiphen bromide dose. Improved performance was the relapse prevention for a duration of at least 28 days in human patients treated for a vulvovaginal Candida (biofilm) infection.

This invention relates to a 30 mg bilayer biphasic-release tablet containing merogabarine or a pharmaceutically acceptable salt thereof, and a method for preparing the same. The tablet is a bilayer tablet consisting of an immediate-release layer and a sustained-release layer, wherein the immediate-release layer accounts for 20%–35% of the total drug content, and the sustained-release layer accounts for 65%–80% of the total drug content. The sustained-release layer contains hydroxypropyl methylcellulose K15M or hydroxypropyl methylcellulose K100M and ethylcellulose. Under the conditions of the second method for release determination in the current edition of the Chinese Pharmacopoeia, the tablet has a predetermined 24-hour release window in any of the media selected from pH 1.2, pH 4.5, and pH 6.8, and maintains a small difference in media values ​​at 8 hours and 12 hours, making it suitable for development into an oral sustained-release formulation for once-daily administration.

The present invention provides a pharmaceutical composition for use in the treatment of follicular lymphoma. [Solution] The pharmaceutical composition comprises 560 mg of a BTK inhibitor and is formulated for a continuous once-daily dosing regimen, and the BTK inhibitor is as follows: JPEG2026065005000042.jpg6042 A pharmaceutical composition having the following structure is provided.

Provided herein are controlled release gastroretentive dosage forms containing deuterated tetrabenazine for use in the treatment of e.g. Hyperactivity dyskinesia. The dosage form provides advantageous pharmacokinetic profiles when orally administered to a subject once a day.

The present disclosure provides methods for treating pulmonary hypertension (PH) in a patient in need thereof, comprising administering via a dry powder inhaler (DPI) to the patient, during an administration period, a compound of Formula (I), (I), or an enantiomer, diastereomer, or a pharmaceutically acceptable salt thereof, wherein R1 is tetradecyl, pentadecyl, hexadecyl, heptadecyl, or octadecyl. In embodiments, during the administration period, the compound of Formula (I), or an enantiomer, diastereomer, or a pharmaceutically acceptable salt thereof, is administered at a starting dose comprising about 80 μg to 160 μg once daily in a single dosing session, and the starting dose is titrated during the titration period to a maximum tolerated dose (MTD) of about 1280 µg or less. In embodiments, the administration period comprises a maintenance period, and the MTD is administered to the patient during the maintenance period. In embodiments, during the administration period, a dose of about 700-1300 µg of the compound of Formula (I), or enantiomer, diastereomer, or a pharmaceutically acceptable salt thereof, is administered once daily in a single dosing session to the patient.

Disclosed are high dose gastric retentive, extended-release lithium salt dosage forms suitable for once a day administration.

The present disclosure is based on a surprising finding that a pH sensitive modified release dosage form is a suitable platform for trazodone therapy. Herein is described a pH sensitive modified release dosage form for once-a-day oral administration of trazodone, or a derivative thereof, comprising from 20% to 50% by weight of the trazodone or the derivative thereof, and from 10% to 80% of a release modifying excipient, which is a hydrogel-forming excipient. The present disclosure is also based on a surprising finding that dosage forms comprising trazodone have particular particle size distribution features that are advantageous for uniform release properties, even upon subdivision. In one such embodiment, less than 35% of the particles are 355μm to 500μm, greater than 5% of the particles are 250μm to 355μm, greater 2% of the particles are 75μm to 150μm, and greater than 5% of the particles are less than 38μm.

This invention relates to pharmaceutical formulations comprising triethylenetetramine tetrahydrochloride (TETA.4HCl). Specifically, it relates to pharmaceutical compositions suitable for once-daily administration to subjects in therapeutic need.

The present invention relates to a sustained-release injectable composition containing dutasteride, which can produce a sustained dutasteride release effect for more than 3 months even when the dosage of dutasteride administered is the same or lower than that of conventional once-daily Avodart®, thereby enabling a sustained drug administration effect for a long period of time with a single injection. In addition, it can continuously provide therapeutic effects for benign prostatic hyperplasia, prostate cancer, and hair loss for more than 3 months, and the microparticles included in the sustained-release injectable composition have a constant average diameter, so the release of the drug can be controlled to maintain a constant effective drug concentration, and the foreign body sensation and pain when administered to a patient as an injection can be reduced.

The specification relates to the administration of small molecule, once-daily, oral glucagon-like peptide-1 receptor agonists for the treatment in a subject in need thereof.

Formulations comprising hydrocortisone are disclosed in a suppository for methods of treating ulcerative colitis and other gastrointestinal diseases and disorders. Administering a single hydrocortisone suppository once a day achieves remission or reduction of a symptom, optionally followed by a period of time in which the dosage is reduced.

The invention discloses a febuxostat enteric-coated sustained-release micro-tablet capsule as well as a preparation method and application thereof, and belongs to the technical field of pharmaceutical preparations. The capsule is a multi-unit drug delivery system and is formed by filling a hard capsule shell with an enteric sustained-release micro-coated chip with the diameter of 1.5-2.5 mm; the micro-coated chip comprises a febux drug-loaded tablet core and is externally coated with a functional coating film, and the coating film is of a single enteric-coated layer or a double-layer structure of a sustained-release layer and an enteric-coated layer. Through prescription-process cooperative control, the release rate of the preparation in 0.1 mol / L hydrochloric acid within 2 hours is less than or equal to 10%, the release rate of the preparation in a phosphate buffer solution with the pH value of 6.8 within 6 hours is 60-85%, and the release behavior conforms to Higuchi or zero-order kinetics and the fitting degree Rgt; and 0.85%. In-vivo research of Beagle dogs shows that Tmax is prolonged to 4.0-8.0 h, Cmax is reduced by 35%-65%, and the blood concentration gt; 100ng / mL is maintained for more than or equal to 12h, the peak-valley fluctuation coefficient is remarkably reduced compared with that of a reference preparation, a blood concentration-time curve is more stable, and administration can be performed once a day. According to the present invention, the defects of large blood concentration fluctuation, multi-time administration and strong gastrointestinal tract stimulation of the rapid release preparation are solved, and the rapid release preparation is suitable for gout and hyperuricemia treatment, and is especially suitable for gastrointestinal tract sensitive patients.

Disclosed is a method and composition for treating non-cirrhotic NASH. A first embodiment of the invention is the administration of a twice daily oral dose of approximately 117-400 mg testosterone equivalent to a subject having liver fibrosis. A second embodiment of the invention is the administration of a once or twice daily oral dose of approximately 117-400 mg testosterone equivalent formulated with approximately 200-600 mg of d-alpha tocopherol equivalent to a subject having liver fibrosis.

Disclosed are high dose gastric retentive, extended-release lithium salt dosage forms suitable for once a day administration.

To provide a method for treating insomnia that is effective and safe even when lemborexant is administered to a patient having moderate hepatic impairment.SOLUTION: Provided is a method comprising orally administering to a patient in need thereof a dosage form comprising lemborexant or a pharmaceutically acceptable salt thereof at a single daily dose ranging from 5 mg to 10 mg of lemborexant or an equivalent dose of a pharmaceutically acceptable salt thereof, provided that when the patient has moderate hepatic impairment classified as Child-Pugh class B under Child-Pugh Classification, the maximum dose is 5 mg once per day of lemborexant or an equivalent dose of a pharmaceutically acceptable salt thereof.SELECTED DRAWING: Figure 1

This invention relates to a 20 mg core-type or core-shell type biphasic-release tablet containing merogabarine or a pharmaceutically acceptable salt thereof, and a method for preparing the same. The tablet is a core-type, compressed-coated tablet, or core-shell type film-coated tablet, comprising an immediate-release portion located in the outer layer or outer coating and a sustained-release portion located in the core, wherein the core is continuously surrounded by the outer layer in the radial direction; the immediate-release portion of the outer layer carries 20%–30% of the total drug content, and the sustained-release portion of the core carries 70%–80% of the total drug content; the core contains hydroxypropyl methylcellulose K15M, polyethylene oxide, and ethylcellulose, suitable for development into an oral sustained-release formulation for once-daily administration.