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Gastroretentive formulations

a technology of gastroretentive formulations and formulations, applied in the direction of pharmaceutical delivery mechanism, organic active ingredients, active ingredients of heterocyclic compounds, etc., can solve the problems of gastric retention coupled with extended drug release, limited bioavailability of conventional oral delivery systems, and significant unproved patient compliance with drug releas

Pending Publication Date: 2021-04-29
RUBICON RES PTY LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

These formulations achieve extended gastric retention and sustained drug release, maintaining effective drug concentrations for an extended period, thereby improving bioavailability and patient compliance by preventing rapid drug elimination.

Problems solved by technology

In most of the cases, the conventional oral delivery systems show limited bioavailability because of fast gastric-emptying time among many other reasons involved.
With gastro-retentive drug delivery systems, gastric retention coupled with drug release for extended time has significantly unproved patient compliance.
Gastro-retentive systems however face issues such as inadequate swelling to cause retention, excessive swelling resulting in rupture of the dosage form.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

Gastroretentive Tablet

[0017]

Ingredientsmg / tabletAtenolol50Ethyl cellulose75Polyethylene oxide250Microcrystalline cellulose100Povidone15Talc4.5Magnesium stearate5.5Total500

[0018]Procedure:

[0019]Atenolol, microcrystalline cellulose, part of ethyl cellulose were blended and granulated with povidone. The granules were then blended with remaining ethyl cellulose, polyethylene oxide, and talc and subsequently lubricated with magnesium stearate.

example 2

-Levodopa Gastroretentive Tablet

[0020]

Ingredientmg / tabActive layerCarbidopa50Levodopa200Hydroxypropyl methyl cellulose,30low viscosityFD&C Red 40Al. Lake0.5Microcrystalline cellulose14.5Magnesium stearate5Total300Gastroretentive layerPolyethylene oxide80Hydroxypropyl methyl cellulose,80higher viscosityCrospovidone80Ethyl cellulose50Microcrystalline cellulose20Polyvinyl pyrrolidone22Isopropyl alcoholqsWaterqsSodium bicarbonate25Citric acid10Mg. stearate3Total370Total tablet weight670 mg

[0021]Procedure: The active layer and gastroretentive layer granulations were made separately and then the two layers were compressed into bi-layered tablets.

example 3

and Hydrochlorthiazide Gastroretentive Tablet

[0022]

Ingredientmg / tabActive layerValsartan160Hydroxypropyl methyl cellulose,30low viscosityMicrocrystalline cellulose50Magnesium stearate5Total245Gastroretentive layerPolyethylene oxide80Hydroxypropyl methyl cellulose,80higher viscosityCrospovidone80Ethyl cellulose50Microcrystalline cellulose20Polyvinyl pyrrolidone22Isopropyl alcoholqsWaterqsSodium bicarbonate25Citric acid10Mg. stearate3Total370Total tablet weight670 mg

[0023]Procedure: The active layer and gastroretentive layer granulations were made separately and then the two layers were compressed into bi-layered tablets. The bi-layered tablet was further coated with a hydroxypropyl methyl cellulose based film coating with 25 mg of hydrochlorthiazide.

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Abstract

The present invention relates to gastroretentive formulations and to processes for preparation of the same. Particularly, the invention relates to gastroretentive dosage forms comprising at least one swelling agent and at least one swelling retardant.

Description

[0001]This application claims the benefit of Indian Provisional Application No. 201921007339, filed Feb. 25, 2019, which is incorporated by reference in its entirety.FIELD OF THE INVENTION[0002]The present invention relates to gastroretentive formulations and to processes for preparation of the same. Particularly, the invention relates to gastroretentive dosage forms comprising at least one swelling agent and at least one swelling retardant.BACKGROUND OF THE INVENTION[0003]Oral formulations have earned a significant place among the various dosage forms developed. In most of the cases, the conventional oral delivery systems show limited bioavailability because of fast gastric-emptying time among many other reasons involved. Retention of the dosage form in the upper gastrointestinal tract for an extended period of time and release of the drug slowly can address many challenges associated with conventional oral delivery, including poor bioavailability. With gastro-retentive drug delive...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/00A61K31/198A61K31/549A61K47/38A61K31/41A61K47/34
CPCA61K9/0065A61K31/198A61K47/34A61K47/38A61K31/41A61K31/549A61K9/2054A61K9/2086A61K9/209
Inventor PILGAONKAR, PRATIBHA
Owner RUBICON RES PTY LTD