# US 9,040,089 B2 · Oral compositions of clindamycin

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- Number: US 9,040,089 B2
- Document ID: US9040089B2
- Status: Granted
- Kind: B2
- Application number: 13/055,004
- Filed: 2008-09-10
- Published: 2011-05-26
- Granted: 2015-05-26
- Earliest claimed: 2008-07-22
- Assignees: Lupin Limited
- Applicants: Kalpana Walzade; Rajesh Kulkarni; Shirishkumar Kulkarni
- Inventors: Kalpana Walzade; Rajesh Kulkarni; Shirishkumar Kulkarni
- Web page: https://patentgrep.com/patent/US9040089B2

## CPC

- A61K 9/0095: {Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches (A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006)}
- A61K 9/1623: {Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules}
- A61K 9/1641: {obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers}
- A61K 9/5026: {obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates}
- A61P 31/04: Antibacterial agents
- A61P 33/02: Antiprotozoals, e.g. for leishmaniasis, trichomoniasis, toxoplasmosis
- A61P 33/06: Antimalarials
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

A taste masked pharmaceutical composition of clindamycin, or a pharmaceutically acceptable salt(s), hydrate(s), solvate(s) and physiologically functional derivative(s) and precursors thereof, which includes all polymorphic forms, whether crystalline or amorphous comprising polyhydric alcohol(s); and one or more other pharmaceutically acceptable excipient(s). A process for preparation of a taste masked pharmaceutical composition of clindamycin or a pharmaceutically acceptable salt(s) thereof the said process comprising the steps of a) dry mixing clindamycin, polyhydric alcohol and other pharmaceutically acceptable excipient(s) to get a dry mixture; b) granulating the dry mixture above with a granulating liquid prepared by mixing the suitable pharmaceutically acceptable excipient(s) with aqueous/non-aqueous fluid to obtain a wet mass; c) drying the wet mass to obtain the discrete particles; d) lubricating the discrete particles obtained with a suitable lubricating agent and/or flavor(s).

## Claims

### Claim 1

A taste masked pharmaceutical liquid composition, comprising:
clindamycin palmitate hydrochloride in an amount 2.646 g; polyethylene glycol; dextrin; sucrose; and optionally artificial sweetener, preservative, flavoring or wetting agent;
wherein clindamycin palmitate hydrochloride is equivalent to 1.5 g of clindamycin free base.

### Claim 2 (depends on 1)

The taste-masked composition according to claim 1 wherein the artificial sweetener is selected from the group consisting of sorbitol, sucrose, saccharin, cyclamates, aspartame, sucralose, thaumatin, acesulfam K, and sugar.

### Claim 3 (depends on 2)

The composition of claim 2, wherein the sugar comprises monosaccharide, disaccharide, or polysaccharide.

### Claim 4 (depends on 1)

The taste-masked composition according to claim 1, wherein the preservative is selected from the group consisting of alkyl hydroxybenzoate, sodium benzoate, potassium sorbate, salts of edetate, and antimicrobial agent.

### Claim 5 (depends on 4)

The composition of claim 4, wherein the antimicrobial agent comprises a paraben.

### Claim 6 (depends on 1)

The taste-masked composition according to claim 1, wherein the flavouring agent is selected from the group consisting of menthol, cinnamon, wintergreen, clove, bay, anise, eucalyptus, thyme, cedar leave, nutmeg, sage, bitter almond, cassia, natural vanilla, artificial vanilla, natural chocolate, artificial chocolate, bubble gum, natural fruit flavor, and artificial fruit flavor.

### Claim 7 (depends on 1)

The taste-masked composition according to claim 1, wherein the wetting agent is selected from the group consisting of sorbitan monolaurate, polysorbate 80, and sodium lauryl sulfate.

### Claim 8 (depends on 1)

The taste-masked composition according to claim 1, comprising about 1% to about 30% of polyethylene glycol.