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Method of treating high plasma cholesterol levels

a plasma cholesterol and plasma technology, applied in the direction of biocide, drug composition, metabolic disorders, etc., can solve the problems of hypercholesterolemia, and achieve the effect of reducing plasma cholesterol levels and reducing side effects

Inactive Publication Date: 2006-08-24
HADVARY PAUL +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0009] The subject invention provides a method of reducing plasma cholesterol levels in a hypercholesterolemic patient. This method comprises administering to the patient a therapeutically effective amount of a lipase inhibitor and a therapeutically effective amount of a bile acid sequestrant. A favored lipase inhibitor is orlistat and preferred bile acid sequestrants include cholestyramine, colestipol, colesevelam, colestimide, sevelamer, cellulose derivatives, dextran derivatives, starch, starch derivatives, and pharmaceutically acceptable salts of such bile acid sequestrants. A key advantage of the subject invention is the mitigations of the side effects associated with both orlistat (oily stool) and bile acid sequestrants (constipation).

Problems solved by technology

Hypercholesterolemia is a great problem in modern society.

Method used

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  • Method of treating high plasma cholesterol levels
  • Method of treating high plasma cholesterol levels
  • Method of treating high plasma cholesterol levels

Examples

Experimental program
Comparison scheme
Effect test

example 1

Study

[0066] The effect of a combination of Orlistat / XENICAL® and a bile acid sequestrant cholestyramine / QUANTALAN® on plasma cholesterol was examined.

[0067] Three hyper-cholesterolemic volunteers, one female, 2 males, started on Orlistat / XENICAL® b.i.d. for 4 weeks to establish a stable plasma cholesterol level: They continued on a combination of Orlistat / XENICAL® b.i.d. and cholestyramine / QUANTALAN® 4 g b.i.d. for a further 4 weeks, which was followed by a 4 week washout period. The effect of this treatment schedule on plasma cholesterol is reported in table 1.

[0068] The plasma cholesterol of all three individuals is reasonably stable at the end of 6 weeks treatment with Xenical b.i.d. After addition of Quantalan b.i.d. to the Xenical b.i.d. treatment plasma cholesterol clearly is reduced further by nearly 20%. The decrease is undoubtedly related to the Quantalan treatment: Upon cessation of Quantalan ingestion plasma cholesterol levels return to the values on Xenical alone.

[00...

example 2

Orlistat Pharmaceutical Compositions

[0071]

QuantityIngredientmg / Capsuleorlistat120.00microcrystalline cellulose (AVICEL PH-101)93.60sodium starch glycolate (PRIMOJEL)7.20sodium lauryl sulfate7.20polyvinylpyrrolidone (Povidone (K-30))12.00purified Water*—talc0.24Total240.24mg

*Removed during processing

Procedure: [0072] 1. Blend orlistat, microcrystalline cellulose, and sodium starch glycolate in a suitable mixer. [0073] 2. Granulate with a solution of polyvinylpyrrolidone and sodium lauryl sulfate in purified water. [0074] 3. Pass the granulation through an extruder and pass the extrudate through a spheronizer to form pellets. [0075] 4. Dry the pellets at 30° C. [0076] 5. Add talc and mix.

[0077] 6. Fill into hard gelatin capsules.

IngredientQuantity mg / Capsuleorlistat60microcrystalline cellulose46.8sodium starch glycolate3.6sodium lauryl sulfate3.6polyvinylpyrrolidone6.0purified water*—talc0.12Total120.12mg

*Removed during processing.

Procedure: [0078] 1. Blend orlistat, microcrys...

example 3

Bile Acid Sequestrant Pharmaceutical Compositions

[0091]

QuantityIngredientmg / Capsulecholestyramine   4 gsilicium Dioxide0.495 gaspartame 0.05 gβ-carotene0.001 gpurified water*—Total 4.5 g

*Removed during processing

Procedure: [0092] 1. Blend colestyramine, and silicium dioxide in a suitable mixer. [0093] 2. Granulate with a solution / colloidal suspension of aspartame and beta-carotene in purified water. [0094] 3. Pass the granulation through an sieve. [0095] 4. Dry the granules at 60° C. [0096] 5. Pass the dry granulation through an sieve [0097] 6. Fill into sachets.

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Abstract

A method prevents or treats diseases associated with high plasma cholesterol levels. In addition, this method reduces plasma cholesterol levels. The method comprises administering a lipase inhibitor, e.g. orlistat, and a pharmaceutically acceptable bile acid sequestrant.

Description

[0001] This application is a continuation of Ser. No. 10 / 313,409, filed Dec. 6, 2002, currently pending, which is a divisional of U.S. patent application Ser. No. 09 / 912,956, filed Jul. 25, 2001, currently pending. The entire contents of the above-identified applications are hereby incorporated by reference.BACKGROUND OF THE INVENTION [0002] 1. Field [0003] The present invention relates to a new method for the prevention and treatment of diseases associated with high plasma cholesterol levels (hypercholesterolemia). [0004] 2. Description [0005] Bile acid sequestrants have been proposed for use in lowering circulating blood cholesterol levels. Biologically, cholesterol is eliminated from the body by conversion to bile acids and excretion as neutral steroids. Bile acids are synthesized from cholesterol in the liver and enter the bile as glycine and taurine conjugates. They are released in salt form in bile during digestion and act as detergents to solubilize and consequently aid in di...

Claims

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Application Information

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IPC IPC(8): A61K31/724A61K31/365A61K31/00A61K47/10A61K31/16A61K31/21A61K31/337A61K31/717A61K31/718A61K31/785A61K45/06A61P3/06
CPCA61K31/00A61K31/365A61K31/785Y10S514/824A61P3/06A61P43/00A61K31/718
Inventor HADVARY, PAULLENGSFELD, HANSSTEFFEN, HANS
Owner HADVARY PAUL
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