Preparation of micron-size pharmaceutical particles by microfluidization
AssigneeWockhardt Europe Limited
InventorVinay K. Sharma
Life of this patent
Estimating the term…
Abstract
The present invention relates to a process of microfluidization or wet-micronization of hydrophobic drugs in combination with dextrins such as β-cyclodextrin. The microfluidized particles are useful in controlled swellability, erosion rate-controlled drug delivery systems. The process of microfluidization facilitates reduction of mean particle size of slightly soluble but highly permeable drugs and creates a smooth, latex-like micro-suspension. A blend of swellable polymer and insoluble, hydrophilic excipients granulated with the micro-suspension create a swellable matrix that after compaction erodes uniformly over a 24-hour period. Optimization of drug release is achieved by modification of the geometry of the drug delivery system.
Claims28
A process for preparing a pharmaceutically active material having an average particle size of from about 1.0 to 15.0 micrometers comprising microfluidizing a composition comprising particulates of a water-insoluble pharmaceutical material, having a solubility of less than 15 mg/ml in an aqueous carrier liquid in the presence of at least 0.01% by weight cyclodextrin particles.
A process for preparing a pharmaceutically active material having an average particle size of from 10 to 1500 nm comprising microfluidizing a composition comprising particulates of a water-insoluble pharmaceutical material, having a solubility of less than 15 mg/ml, in an aqueous carrier liquid in the presence of at least 0.01% by weight of cyclodextrin particles until a particle size range of from 10 to 1500 nm is attained for the pharmaceutically active material.
Dependencies are inferred from the claim text.