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Pharmaceutical Formulation

a technology of pharmaceutical formulation and formulation, applied in the direction of drug composition, microcapsule, capsule delivery, etc., can solve the problems of less therapeutically effective formulation towards the end of the twelve-hour period, concomitant increase in side effects, and little benefit in combining a drug such as codeine with a drug, so as to reduce the observed food

Inactive Publication Date: 2016-08-11
RB HEALTH (US) LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The patent invention allows for independent control of releasing the second active ingredient (the coated drug-resin complex) without affecting the dissolution properties of guaifenesin. This helps to reduce the impact of food on drugs that show lipid variability in clinical evaluation and protects actives fromcompatibility concerns that may lead to stability degradation.

Problems solved by technology

As a result, there is little benefit to be gained in combining an antitussive such as codeine with a drug having a shorter or longer therapeutically effective period in a single dosage form.
Furthermore, most formulations that claim twelve hour potency release almost their entire drug within six to eight hours, making the formulation less therapeutically effective towards the end of the twelve hour period.
The increase in drug strength, however, results in a concomitant increase in side-effects.
Although this solution improves the Cmax and length of time before the drug appears in the blood stream in some formulations, the extended therapeutic effect is not improved.

Method used

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  • Pharmaceutical Formulation

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Embodiment Construction

[0047]To facilitate an understanding of the principles and features of the various embodiments of the invention, various illustrative embodiments are explained below. Although preferred embodiments of the invention are explained in detail, it is to be understood that other embodiments are contemplated. Accordingly, it is not intended that the invention is limited in its scope to the details of ingredients and arrangement of components set forth in the following description or illustrated in the drawing. The invention is capable of other embodiments and of being practiced or carried out in various ways. Also, in describing the preferred embodiments, specific terminology will be resorted to for the sake of clarity.

[0048]It must also be noted that, as used in the specification and the appended claims, the singular forms “a,”“an” and “the” include plural references unless the context clearly dictates otherwise. For example, reference to an ingredient is intended also to include composit...

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Abstract

A pharmaceutical composition in the form of a tablet including a first portion and a second portion, wherein the first portion includes guaifenesin having an immediate release profile and a second drug having a sustained release profile, and wherein the second portion includes guaifenesin having a sustained release profile. The second drug can be in the form of a drug-resin complex. The second drug can be either an anti-tussive or a decongestant. The drug-resin complex includes a drug complexed to an ion exchange resin. The ion exchange resin can be a polystyrene sulfonate resin, polacrilex resin, polacrilin potassium, cholestyramine resin, or a colestyramine resin. The drug-resin complex can be provided with a coating, the coating thickness being selected to obtain the desired release profile. The drug-resin complex can be provided with a coating level of from 5% to 50%. The coating level can be from 10% to 35%.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation of application Ser. No. 13 / 021,240, filed 4 Feb. 2011, which is incorporated herein by reference in its entirety as if fully set forth below.BACKGROUND OF THE INVENTION[0002]1. Field of the Invention[0003]The present invention is directed to a novel pharmaceutical composition comprising guaifenesin and a second drug. In particular, the present application is directed to a novel pharmaceutical composition comprising guaifenesin and a second drug which is an antitussive or a decongestant. More particularly, the present application is directed to a composition comprising guaifenesin having both immediate and extended release profiles and codeine having an immediate release profile.[0004]2. Description of Related Art[0005]Compounds such as codeine are known to have both antitussive and pain relieving properties. The antitussive effect occurs at a lower dose than that needed to provide pain relief.[0006]In ad...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/09A61K9/20A61K9/48A61K9/50A61K31/485A61K9/24
CPCA61K9/2027A61K9/5042A61K9/209A61K9/5047A61K31/09A61K31/137A61K31/485A61K45/06A61K9/2054A61K9/4808A61K9/5026A61K9/20A61K2300/00A61P11/00A61P11/02A61P11/10A61P11/14
Inventor AHLGREN, NILSNUTTALL, MARKWONG, JEANNIEBALASUBRAMANIAN, VENKATESHBELONGIE, CRAIGKHAN, ASHFAQMUIR, NEIL CAMPBELL
Owner RB HEALTH (US) LLC
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