Process for preparing solid pharmaceutical dosage forms of hydrophobic substances

A technology for hydrophobic drugs and hydrophobic substances, which is applied in the fields of pharmaceutical formulation, drug delivery, pill delivery, etc. It can solve the problems of aggravation, uneven drug content, and the impossibility of preparing suspensions, so as to prevent foam and ensure uniformity Effect

Inactive Publication Date: 2006-01-18
R P SCHERER GMB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For many drugs, due to their hydrophobic nature, a stable foam is formed during mixing, making it impossible to prepare a homogeneous suspens

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0044] The free base form of domperidone was formulated as an oral rapidly disintegrating formulation with the following ingredients.

[0045] Domperidone Fine Powder 10.000mg

[0046] (average particle size less than 50μm)

[0047] Gelatin 5.513mg

[0048] Mannitol 4.136mg

[0049] Saccharin 0.75mg

[0050] Mint flavor 0.30mg

[0051] Poloxamer 188 1.125mg

[0052] pure water

[0053] A solution containing gelatin, mannitol and poloxamer 188 was prepared and saccharin and mint flavor were added to it. Add an aliquot of the resulting solution to the domperidone powder and stir to form a paste. The remaining solution was added to obtain a homogeneous suspension. The suspension was dispensed into blister packs in 150 mg aliquots, frozen and dried to produce the final dosage form.

[0054] The bioavailability of this domperidone final dosage form product is the same as that of a compressed tablet containing the same amount of domperidone. However, the bioavailability of...

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Abstract

A process for the preparation of an oral rapidly disintegrating dosage form of a hydrophobic pharmaceutically active substance which process comprises forming a suspension of the hydrophobic pharmaceutically active substance in a solvent containing a pharmaceutically acceptable surfactant together with a water-soluble or water-dispersible carrier material, forming discrete units of the suspension and removing solvent from the discrete units under conditions whereby a network of the carrier material carrying a dosage of the hydrophobic pharmaceutically active substance is formed.

Description

technical field [0001] The invention relates to a method for preparing a solid drug dosage form of a drug active substance, in particular to a method for preparing an oral solid rapidly disintegrating dosage form of a drug active substance. Background technique [0002] Many pharmaceutically active substances are administered orally in the form of tablets, pills or capsules. Tablets, pills or capsules are generally swallowed with water to allow the pharmaceutically active substance to be absorbed through the gastrointestinal tract. Swallowing tablets, pills, or capsules is difficult or impossible for some patients, especially children and elderly patients. Similar difficulties are often encountered when attempting to administer tablets to non-human animals, who may not cooperate when taking tablets, pills or capsules. [0003] GB-A-1548022 and GB-A-2111423 propose oral solid pharmaceutical dosage forms that disintegrate rapidly in the mouth and their preparation methods. ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/00
CPCA61K9/0056A61K9/2095
Inventor R·J·亚伍德P·基尔尼A·R·汤普森
Owner R P SCHERER GMB
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