Orally disintegrating tablets comprising glycopyrrolate and methods for increasing bioavailability

A technology of glycopyrronium bromide and disintegrant, which is applied in the field of orally disintegrating pore glycopyrronium bromide tablets, and can solve problems such as the bioavailability of unspecified compounds

Pending Publication Date: 2021-12-10
伊登布里奇制药有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] US 5,298,261 provides a method for preparing vacuum-dried tablets, but there is no indication in US 5,298,261 that this method can be used with quaternary ammonium compounds without affecting the bioavailability of the compound

Method used

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  • Orally disintegrating tablets comprising glycopyrrolate and methods for increasing bioavailability
  • Orally disintegrating tablets comprising glycopyrrolate and methods for increasing bioavailability
  • Orally disintegrating tablets comprising glycopyrrolate and methods for increasing bioavailability

Examples

Experimental program
Comparison scheme
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Embodiment 1

[0063] Example 1 - Comparative Pharmacokinetics and Bioavailability Analysis

[0064] Oral tablets containing 2 mg glycopyrronium bromide were prepared by mixing a liquid formulation containing glycopyrronium bromide, mannitol, gelatin, poloxamer 188, sucralose, flavoring, and citric acid with water as shown in Table 1. Disintegrate pogoronium bromide tablets. Adjust the pH of the liquid formulation to 4.0-5.0. The suspension is then freeze-dried and tablets are produced. The resulting tablets were used as test oral bengeglurronium bromide tablets (Test ODT) in the pharmacokinetic and bioavailability analyses, reported below.

[0065] Pharmacokinetic and bioavailability analyzes were performed on oral bengyrronium bromide tablets (test ODT) containing 2 mg glycopyrronium bromide. The analysis was performed in comparison to a reference oral tablet from the company Par Pharmaceutical, also containing 2 mg glycopyrronium bromide, referred to as the reference tablet.

[0066]...

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Abstract

Orally-disintegrating porous tablets with microscopic pores comprising an effective amount of glycopyrrolate with the disintegration rate in the mouth of less than 60 seconds and an increased bioavailability. Methods for treating sialorrhea, controlling excessive production of stomach acid, controlling excessive sweating, managing stomach and / or abdominal pain, and treating drug-induced arrhythmia.

Description

technical field [0001] The present disclosure relates to orally disintegrating porosyrrolate tablets with increased bioavailability and methods wherein the tablets are used for administration to a patient. Background technique [0002] Glycopyrronium bromide is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidine bromide. Its empirical formula is C 19 h 28 BrNO 3 , and its molecular weight is 398.33. Glycopyrrolate is the drug ROBINUL R active ingredient in. [0003] Glycopyrrolate is an anticholinergic drug known to combat muscarinic symptoms. Therefore, it can be used to control the volume and free acidity of gastric secretions. Glycopyrrolate can also be used to control excessive pharyngeal, tracheal, or bronchial secretions. Glycopyrrolate is used as an adjunct to anesthesia in the preoperative setting or during sedation. Glycopyrrolate can also be used to combat some postoperative effec...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/40A61K31/4015A61K9/20
CPCA61K31/40A61K9/2095A61K9/2013A61K9/2018A61K9/2063A61K9/2031A61K9/0056A61K45/06A61K9/19A61P1/04A61P9/06A61P43/00A61K9/2072A61K47/12A61K31/4015
Inventor T·费尔南德斯C·邦德L·J·布雷特L·P·格罗瑟
Owner 伊登布里奇制药有限公司
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