COATING OF PARTICLES COMPRISING A PHARMACEUTICALLY ACTIVE INGREDIENT WITH A CARBONATE SALT OR PHOSPHATE SALT
First Claim
1. A process for coating a particle comprising a pharmaceutically active ingredient (API) comprising the steps of:
- a) providing a composition comprising carbonate ions, phosphate ions, or a mixture thereof,b) providing particle(s) comprising an API, andc) precipitating a carbonate salt, a phosphate salt or a mixture thereof onto the particle(s) comprising the API, wherein the precipitation is carried out in a suspension having a pH of 4 or higher, wherein a solvent used is water optionally supplemented with organic solvent(s) up to 10 volume %, wherein API has a solubility of less than 1 mg/ml at pH 6.8 in the solvent(s) used in the process.
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Abstract
The present invention belongs to the field of pharmaceutical industry and relates to a process for coating a particle comprising a pharmaceutically active ingredient (API) comprising the steps of providing a composition comprising carbonate ions, phosphate ions, or a mixture thereof, providing a particle comprising an API, and precipitating a carbonate salt, a phosphate salt or a mixture thereof onto said particles.
The present invention is also directed to a particle comprising an API, wherein the particle is coated with a coating comprising a carbonate salt, phosphate salt, or mixture thereof, and to a pharmaceutical composition comprising said particles.
Moreover, the present invention is also directed to the use of said particles for preparing a medicament,
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Citations
19 Claims
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1. A process for coating a particle comprising a pharmaceutically active ingredient (API) comprising the steps of:
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a) providing a composition comprising carbonate ions, phosphate ions, or a mixture thereof, b) providing particle(s) comprising an API, and c) precipitating a carbonate salt, a phosphate salt or a mixture thereof onto the particle(s) comprising the API, wherein the precipitation is carried out in a suspension having a pH of 4 or higher, wherein a solvent used is water optionally supplemented with organic solvent(s) up to 10 volume %, wherein API has a solubility of less than 1 mg/ml at pH 6.8 in the solvent(s) used in the process. - View Dependent Claims (4, 5, 6, 8, 9, 11, 12, 13)
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2. A process for coating a particle comprising a pharmaceutically active ingredient (API), comprising the steps of:
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a) providing a composition comprising carbonate ions, phosphate ions, or a mixture thereof, b) providing particle(s) comprising an API, and c) precipitating a carbonate salt, a phosphate salt or a mixture thereof onto the particle(s) comprising the API, and wherein the precipitation is achieved by gradually combining the carbonate ions, the phosphate ions or the mixture thereof with counter ions in the presence of the particle(s) comprising the API, wherein a solvent used is water optionally supplemented with organic solvent(s) up to 10 volume %, wherein API has a solubility of less than 1 mg/ml at pH 6.8 in the solvent(s) used in the process. - View Dependent Claims (3, 7, 10)
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- 14. A particle comprising a pharmaceutically active ingredient (API), the particle being coated with a coating comprising a carbonate salt, phosphate salt, or mixture thereof, wherein API has a solubility of less than 1 mg/ml at pH 6.8 in water.
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18. (canceled)
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19. A method of taste masking of a pharmaceutically active ingredient (API) comprising
a) providing a composition comprising carbonate ions, phosphate ions, or a mixture thereof, b) providing particle(s) comprising an API, and c) precipitating a carbonate salt, a phosphate salt or a mixture thereof onto the particle(s) comprising the API to form coated API particles, wherein the precipitation is carried out in a suspension having a pH of 4 or higher, wherein a solvent used is water optionally supplemented with organic solvent(s) up to 10 volume %, wherein API has a solubility of less than 1 mg/ml at pH 6.8 in the solvent(s) used in the process, wherein the taste of the API in the particles is masked.
Specification