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Novel clonidine formulation

a technology of clonidine and formulation, which is applied in the direction of biocide, animal repellents, dispersed delivery, etc., can solve the problems of unwanted sedating effects and failure to provide detailed illustrations of how, and achieve the effect of high tensile strength

Inactive Publication Date: 2014-04-03
TRIS PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This results in unwanted sedating effects during the day time.
However, the document fails to provide any detailed illustrations of how to formulate clonidine so as to achieve the described release profile.

Method used

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  • Novel clonidine formulation
  • Novel clonidine formulation
  • Novel clonidine formulation

Examples

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example 1

Preparation of Clonidine Tablet Formulation: Barrier Coated Clonidine—Cation Exchange Resin Complex Matrix Modified Release Tablets, Equivalent to 0.2 mg Clonidine HCl

[0086]A. Preparation of Uncoated Clonidine—Cation Exchange Resin Complex Matrix

IngredientsGrams / batchClonidine HCl85Sodium Polystyrene Sulfonate12750(Amberlite ™ IRP-69) CationExchange ResinPovidone (Kollidon ® 30)1134Purified Water*qs**Removed during processing

[0087]The clonidine—resin complex matrix was prepared by first adding 80 L of purified water into a vessel and dissolving clonidine HCl therein by continuous mixing. A sodium polystyrene sulfonate ion exchange resin (AMBERLITE™ IRP-69) was dispersed with continuous mixing to form a slurry and the mixing was continued for 60 minutes to permit formation of a clonidine—ion exchange resin complex. Water from the slurry was removed by filtration. The wet resin complex was rinsed twice using purified water and then dried until the moisture content was about 10% to abo...

example 2

Barrier Coated Clonidine—Cation Exchange Resin Complex Matrix Tablets, Equivalent to 0.3 Mg Clonidine HCl

[0092]A. Preparation of Uncoated Clonidine—Cation Exchange Resin Complex Matrix

Ingredientsgms / BatchClonidine HCl85Sodium Polystyrene Sulfonate12750(Amberlite ™ IRP-69) CationExchange ResinPovidone (Kollidon ™ 30)1134Purified Water*Qs**Removed during processing

[0093]The clonidine—cation exchange resin complex was prepared by adding 80 L of purified water in to a vessel and then clonidine HCl, which was dissolved by continuous mixing. Sodium polystyrene sulfonate (AMBERLITE™ IRP-69) was dispersed in the vessel with continuous mixing to form a slurry and the mixing was continued for 60 minutes in order to permit formation of the clonidine—cation exchange resin complex. Water from the slurry was removed by filtration process. The wet clonidine—ion exchange resin complex was rinsed twice using purified water. This wet resin complex was then dried until the moisture content was about 1...

example 3

Preparation of Barrier Coated Clonidine—Ion Exchange Resin Complex Matrix Liquid Suspension Formulation

[0098]A. Preparation of Uncoated Clonidine—Cation Exchange Resin Complex Matrix

Ingredientsgms / BatchClonidine HCl85Sodium Polystyrene Sulfonate12750(Amberlite ™ IRP-69) CationExchange ResinPovidone (Kollidon ™ 30)1134Purified Water*Qs**Removed during processing

[0099]The clonidine—cation exchange resin complex was prepared by first adding into a vessel 80 L of Purified Water and dissolving clonidine HCl therein by continuous mixing. A sodium polystyrene sulfonate cation exchange resin (AMBERLITE™ IRP-69) was dispersed with continuous mixing to form a slurry and the mixing was continued for 60 minutes in order to permit complexation of the clonidine and the cation exchange resin. Water from slurry was removed by filtration process. The wet clonidine—cation exchange resin complex was rinsed twice using purified water. This wet resin complex was then dried until the moisture content was...

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Abstract

An oral clonidine dosage unit providing a twenty-four hour extended release profile following a single dose administration is provided. The dosage unit comprises a pharmaceutically effective amount of a coated complex comprising clonidine bound to a cationic exchange resin, which is characterized by a twenty-four hour release profile with a single peak, wherein said oral clonidine dosage unit provides a therapeutically effective plasma concentration for at least about 70%, or at least 85% of the twenty-four hour period following the single dose administration. Both liquid and solid formulations are provided, as are methods of treating a patient by a single administration of a formulation of the invention so as to achieve a therapeutic effect for 24-hours.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation of U.S. patent application Ser. No. 12 / 908,796, filed Oct. 20, 2010, now pending. This application is hereby incorporated by reference.BACKGROUND OF THE INVENTION[0002]This invention relates generally to formulations containing clonidine, and more specifically, to a formulation providing a twenty-four hour release profile in a single daily dosage unit.[0003]Clonidine (known chemically as N-(2,6-dichlorophenyl)-4,5-dihydro-1H-imidazol-2-amine) is characterized by the structure:The pharmaceutical product containing the hydrochloride salt of clonidine is commercially available as Catapres® (USP from Boehringer Ingelheim Pharmaceuticals, clonidine hydrochloride or 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride, MW 266.56). Catapres® is a centrally acting alpha-agonist hypotensive agent available in tablet form for oral administration in three dosage strengths: 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg t...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/16A61K31/4168
CPCA61K31/4168A61K9/1635A61K9/0095A61K9/10A61K9/2027A61K9/2054A61K9/2081A61K9/5026
Inventor MEHTA, KETANTU, YU-HSING
Owner TRIS PHARMA
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