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Controlled release compositions with reduced food effect

A food effect and composition technology, applied in the direction of drug combination, medical preparations containing active ingredients, organic active ingredients, etc., can solve the problems of not being clinically effective, poor drug absorption, etc.

Inactive Publication Date: 2013-04-10
TWI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, these drug formulations are not preferred because drug absorption can vary with the type and amount of food
For example, if a patient forgets to take a drug formulation with food, the drug may not be absorbed well and therefore not be clinically effective

Method used

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  • Controlled release compositions with reduced food effect
  • Controlled release compositions with reduced food effect
  • Controlled release compositions with reduced food effect

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0081] A preparation of controlled release composition

[0082] A controlled release tablet containing 1000 mg of metformin hydrochloride is prepared as follows:

[0083] (a) Sustained release layer

[0084]

[0085] HPMC K100LV CR was dissolved in pure water as a binder solution. Metformin hydrochloride, Na 2 HPO 4 Mix with a portion of HPMC K100M CR (inside) and pass through a 30 mesh screen. The blended powders were wet granulated by sparing with the binder solution in a high shear mixer. The granules were dried at 70°C in a fluid bed granulator until the loss on drying did not exceed 3%. Pass the dried granules through a Comil fitted with a 20# mesh screen. HPMC K100M CR (external) was passed through a 30# mesh screen and mixed with the dry granules through a V-blender. Magnesium stearate was passed through a 30# mesh screen and blended with the mixture.

[0086] (b) Instant release layer

[0087]

[0088] Will EF was dissolved in pure water as a binder so...

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PUM

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Abstract

The present invention provides a controlled release pharmaceutical composition which exhibits reduced food effect.

Description

Background of the invention [0001] Oral administration of drugs is often affected by food-drug interactions, a phenomenon commonly described by the term "food effect". As generally explained, food effect is a very broad term referring to the effect of food on all aspects of drug dissolution, absorption, distribution, metabolism and excretion. The meaning of food effect includes bioavailability, speed of onset of action, duration of therapeutic effect, and incidence and severity of side effects. [0002] Food effects are very important issues during drug development. In certain instances where food-drug interactions lead to increased drug absorption, it is recommended that the drug formulation be ingested with food in order to be fully absorbed and exert its desired clinical effect. However, these drug formulations are not preferred because drug absorption can vary with the type and amount of food. For example, if a patient forgets to take a drug formulation with food, the d...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20
CPCA61K31/00A61K38/26A61K38/28A61K31/155A61K9/2009A61K9/209A61P3/00A61P3/10A61K9/20
Inventor 陈守琼李少明詹秋明
Owner TWI PHARMA
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