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Pharmaceutical composition with anti-obesity activity comprising a premixture of pure orlistat and preparation process

一种预混合物、奥利司他的技术，应用在药物组合、有机活性成分、含有效成分的医用配制品等方向

Inactive Publication Date: 2012-10-17
LAB BAGO +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0026] iv) Since the preparation of pills requires different stages and special equipment, which creates additional costs besides the industrial preparation of the pharmaceutical form

Method used

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  • Pharmaceutical composition with anti-obesity activity comprising a premixture of pure orlistat and preparation process
  • Pharmaceutical composition with anti-obesity activity comprising a premixture of pure orlistat and preparation process
  • Pharmaceutical composition with anti-obesity activity comprising a premixture of pure orlistat and preparation process

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0115] Example 1: Premix for the preparation of a pharmaceutical composition comprising 60 mg orlistat per unit preparation of

[0116] step:

[0117] A) Using an 813 micron screen, sieve the following ingredients in a Quadro Comill Mod 197S conical sieve mill, etc.:

[0118]

[0119] Added to Erweka AMD motor type 5V1M rotary screen with FGS type attachment and equivalent cone mixer.

[0120] B) Mix for 30 minutes.

[0121] C) Sift under the same conditions and add to the cone mixer:

[0122] Sodium Stearyl Fumarate (PRUV) 15.00g

[0123] D) Mix for 5 minutes.

[0124] E) Store the mixture in an airtight container.

[0125] - The amount of orlistat mentioned above (if necessary) has to be adjusted according to the title of the active ingredient.

[0126] - Obtain 1 kg of premix.

[0127] - The obtained bulk premix (1 kg) can be used indiscriminately for the preparation of notched, coated tablets or powder for oral suspension.

[0128] - About 2500 units can b...

Embodiment 2

[0129] Example 2: Preparation of Scored, Coated Tablet Containing 60 mg Orlistat step:

[0130] A) direct compression

[0131] The bulk mixture of orlistat and other ingredients prepared in Example 1 was compressed in a Riva Piccola Model B-2 rotary compressor or similar compressor equipped with 6 punching tools and with Autoset HI TECH to 400mg theoretical weight.

[0132] - Obtain tablets with the following properties:

[0133] a) weight:

[0134] Average weight: 400mg (390-410mg)

[0135] Measuring equipment: Mettler Toledo AB 204-S balance with LC P45 printer

[0136] b) hardness: 15-25Sc

[0137] Measuring equipment: ERWEKA type TBH 30MD hardness tester

[0138] c) Crispness: less than 0.5%

[0139] Measuring equipment: drug friability equipment

[0140] d) Disintegration: Less than 10 minutes in water at 37°C.

[0141] Measuring equipment: AVIC disintegration equipment

[0142] Arrange the sieved tablets in a suitable container.

[0143] B)...

Embodiment 3

[0163] Example 3: Oral suspension in single-dose sachets containing 60 mg orlistat per unit Preparation of the powder

[0164] step:

[0165] 1) Prepare a bulk premix or orlistat comprising the following ingredients according to Example 1:

[0166]

[0167]

[0168] 2) Separately sieve in a Quadro Comill 197 S conical sieve mill using an 813 micron screen:

[0169]

[0170]Both powder mixtures from step 1 and step 2 were added to an Erweka AMD motor type 5V1M rotary sieve or similar with FGS type attachment and conical mixer.

[0171] 3) Mix for 20 minutes.

[0172] 4) Portioning and packaging of single-dose sachets:

[0173] In a humid environment at an appropriate temperature, Rovema-type sachets are equally portioned, etc., in a proportioning dosing machine using:

[0174] Foil 83g / m 2 +Pe 40μ crystal (triple foil)

[0175] It is then packaged according to the following specifications:

[0176] -Theoretical fill weight: 3500mg

[0177] - Maximum all...

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PUM

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Abstract

Pharmaceutical compositions with anti-obesity activity that act peripherally are provided, which comprise a premixture made up of pure orlistat as the active ingredient and other components that afford the premixture stability and suitable physical properties for simply preparing compositions for oral use with convenient dosage flexibility; and optionally necessary thickening, flavouring and colouring agents. A method for preparing said compositions is also provided. The orlistat content in the premixture is less than 20% of the total weight of the mass, preferably between 12 and 17 %. The pharmaceutical composition can be formulated indistinctively from the premixture both as grooved tablets and powder for suspension.

Description

technical field [0001] The present invention relates to a pharmaceutical composition with anti-obesity activity, acting peripherally and comprising a premixture consisting of pure orlistat (orlistat) and other ingredients that impart stability and suitable physical properties to the premix for simple preparation of oral compositions with convenient dosage flexibility. The invention also relates to methods of preparing said compositions. Background technique [0002] About one-third of Americans between the ages of 20 and 70 are considered obese, and about half of the U.S. population within this age group is considered overweight. Obesity is also recognized as a growing problem in other industrialized countries and in emerging countries where large numbers of people are accustomed to a calorie-rich diet influenced by the West. Obesity is estimated to play a role in up to 50% of chronic diseases in Western societies and is responsible for 70% of foreseeable deaths in the Uni...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K9/14A61K9/16A61K31/365A61K9/20
CPCA61K9/282A61K9/2054A61K9/0095A61K9/2018A61K9/5084A61K9/145A61K31/365A61K9/286A61P3/00A61P3/04
Inventor 马里奥·阿蒂略·洛斯
Owner LAB BAGO