Diphenhydramine tannate liquid and semi-solid compositions and methods of use

a technology of diphenhydramine and composition, applied in the direction of drug composition, biocide, capsule delivery, etc., can solve the problems of complex, non-uniform chemistry, and significant amount of volatile solvent used during preparation (up to about 5-10%) cannot be effectively removed

Inactive Publication Date: 2005-03-31
KIEL LAB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0013] The present invention relates to a therapeutic composition for symptomatic treatment of respiratory allergies in a warm-blooded animal where that composition comprises a pharmaceutically effective amount of diphenhydramine tannate of c

Problems solved by technology

It is typically produced from Turkish or Chinese nutgall and has a complex, non-uniform chemistry.
Diphenhydramine also possesses a pronounced tendency to induce sedation.
However, antihistamine tannate salts are heat sensitive and therefore undergo decomposition quite readily upon prolonged exposure to temperatures as low as 50 degrees C. In addition, the yield obtained is usually only about 70% and impurities including decomposition products and a significant amount of the volatile solvent used during preparation (up to about 5-10%) cannot be effectively removed.
This causes significant processing problems during manufacture

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example

[0046]

IngredientMilligrams per 5 mLDiphenhydramine Tannate25.0Xanthan gum27.5Magnesium Aluminum Silicate40.0Sodium Benzoate5.0Methylparaben10.0Sucrose50.0Saccharin Sodium5.0Glycerin375.0Artificial Strawberry Flavor15.0FD&C Red #403.0Purified Water,USP (Deionized) adjust to 5 mL.

[0047] Tannic acid may also be used for pH adjustment. Monobasic sodium phosphate, USP, and Dibasic sodium phosphate, USP, Anhydrous may also be included in the formula for pH adjustment.

[0048] For the purpose of this disclosure, a warm-blooded animal is a member of the animal kingdom possessed of a homeostatic mechanism and includes mammals and birds.

[0049] The dosage administered will be dependent on the age, health and weight of the recipient, kinds of concurrent treatment, if any, frequency of treatment and effect desired. Typically, from about 25 to about 50 mg of the diphenhydramine are administered to adults and children over twelve years of age every four to six hours up to a maximum of about 300 mg...

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Abstract

Pharmaceutical compositions consisting of diphenhydramine tannate which are effective when administered for the symptomatic relief of sneezing, itchy, watery eyes, itchy nose or throat and runny nose due to hay fever (allergic rhinitis) or other respiratory allergies are disclosed.

Description

[0001] This is a continuation-in-part of U.S. patent application Ser. No. 10 / 119,285 filed Apr. 9, 2002 which claims the benefit of Provisional Patent Application Ser. No. 60 / 282,969 filed Apr. 10, 2001.FIELD OF INVENTION [0002] The invention relates to novel antihistaminic tannate compositions. The compositions contain as an essential ingredient diphenhydramine tannate. BACKGROUND OF THE INVENTION [0003] Tannins are water-soluble phenolic metabolites of plants with a molecular weight of 5-5000 Da. Physicochemically, tannins are complex polymers, which can be classified as two major types: the condensed tannins and hydrolyzable tannins. Hydrolyzable tannins or tannic acids are referenced in the various pharmacopeias and are composed of gallic acid or its condensation product ellagic acid esterified to the hydroxyl groups of glucose. Each hydrolyzable tannin molecule is usually composed of a core D-glucose and 6 to 9 galloyl groups. [0004] In nature, there is an abundance of mono and...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K9/20A61K9/48A61K31/205A61K31/7024
CPCA61K9/007A61K9/2004A61K9/4858A61K9/4866A61K31/205Y10S514/855Y10S514/937Y10S514/849Y10S514/85Y10S514/853A61K31/7024
Inventor KIEL, JEFFREY S.THOMAS, H. GREGMANI, NARASIMHAN
Owner KIEL LAB
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