Progestogen formulations and uses thereof

A solvent and solubilizer technology, applied in the field of medicine, can solve pain and other problems

Pending Publication Date: 2021-11-09
SHENZHEN EVERGREEN THERAPEUTICS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Most of the progesterone preparations currently available on the market are injections, but injections have some disadvantages, such as pain during injection, etc.

Method used

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  • Progestogen formulations and uses thereof
  • Progestogen formulations and uses thereof
  • Progestogen formulations and uses thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-17

[0176] Example 1-17-Pharmacological study of HPC in smoke exposure-induced COPD rats

[0177] In order to examine the in vitro and in vivo efficacy of 17-HPC inhalation in chronic obstructive pulmonary disease (COPD) rats, a COPD rat model was established by exposing Wistar rats to CS for 1 hour per day for a total of 180 days, administered by aerosol inhalation. medicine. 72 Wistar rats were randomly divided into blank control group, model group, 17-HPC (0.5mg / ml, 0.25mg / ml and 0.1mg / ml) group, BUD (0.5mg / ml and 0.1mg / ml) group , and combined treatment (0.5mg / ml BUD+0.25mg / ml 17-HPC and 0.1mg / ml BUD+0.25mg / ml 17-HPC) group. The drug concentration is the concentration of the nebulized solution. Rat lung function (forced vital capacity) was measured using a small animal spirometer and differential counts in the BALF were determined microscopically. Serum and BALF cytokine (IL-6, IL-17, TNF-α and IL-β) levels were measured by ELISA. HE staining was used to measure the infilt...

Embodiment 2

[0183] Example 2-Seven-day atomization inhalation toxicity study on rats

[0184] A 7-day inhalation toxicity study in rats was conducted under GLP conditions. In this study, Sprague-Dawley rats (10 / sex / group) were administered aerosolized 17-HPC at 8, 24 and 72 mg / kg / day for 7 consecutive days. Rats in the control group were given nebulized vehicle. Animals were observed daily for clinical signs. Body weight and food consumption were recorded at pretest and then on days 1, 4 and 7. To assess the reversibility of 17-HPC treatment, groups of satellite rats (5 / sex / group) were dosed by inhalation at 72 mg / kg / day for 7 days and sacrificed on day 14. All animals were sacrificed on day 8 except rats in the satellite group. Hematological and biochemical tests were performed at the end of the study. Organ weights, gross pathology and histopathology assessments were performed.

[0185] The preliminary results of this experiment showed that no clinical symptoms and body weight cha...

Embodiment 3

[0187] Example 3-PK Analysis Report of Oral PR2005 Formula for Bitches

[0188] In this study, the pharmacokinetic parameters of the experimental drug PR2005 in different formulations were determined after oral administration in dogs. The study further determined the relative bioavailability of the test drug PR2005 in each formulation, compared to the intramuscular solution.

[0189] PK analysis method:

[0190] Estimation of PK parameters, including maximum plasma concentration (Cmax), time to Cmax (Tmax), time lag during absorption (Tlag), plasma concentration-time profile from time 0 to the last quantifiable data point (AUClast) Area under (AUCinf), plasma half-life (t1 / 2), apparent plasma clearance (CL / F), apparent volume of distribution (Vz / F). All these parameters were calculated using standard non-isolated analysis methods. Geometric means and %CVs are reported for most PK parameters, and median and ranges for Tmax and Tlag are reported. Plasma PR2005 PK data of Phe...

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Abstract

Disclosed herein, in certain embodiments, are compositions, solutions, and soft gelatin capsules comprising 17-alpha hydroxyprogesterone caproate (17-HPC). In certain embodiments, also disclosed herein are methods, dosing regimens, and kits for use in the treatment of a disease or condition.

Description

technical field [0001] The present invention relates to progesterone preparation and application thereof, in particular to the composition of 17-alpha-hydroxyprogesterone caproate (17-HPC) and a two-component solvent system, as well as soft gelatin capsules, kits and the like containing the composition The use belongs to the technical field of medicine. Background technique [0002] Most progesterone preparations currently available on the market are injections, but injections have some disadvantages, such as pain during injection. Therefore, it is necessary to develop new dosage forms. [0003] For this reason, the inventor of the present application has created the oral preparation of hydroxyprogesterone caproate for the first time in the world. The advantages of oral preparations are that they are easy to use, without the pain of injections, and are highly acceptable to patients. Therefore, the present invention provides a novel oral agent and its application. Conten...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/57A61K9/08A61K47/14A61K47/12A61K47/10A61K47/44A61K47/26A61K9/48A61K45/06A61K31/573A61K31/58A61P11/00A61P11/06A61P43/00A61P1/00A61P1/04
CPCA61K31/57A61K9/08A61K9/0053A61K47/14A61K47/12A61K47/10A61K47/44A61K47/26A61K9/4858A61K9/4866A61K9/4825A61K9/0019A61K45/06A61K31/573A61K31/58A61P11/00A61P11/06A61P43/00A61P1/00A61P1/04A61K2300/00Y02A50/30A61P31/00A61K9/0043A61K9/0014A61K9/006A61K9/0073
Inventor 杜新杜涛滑维薇
Owner SHENZHEN EVERGREEN THERAPEUTICS CO LTD
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