Aqueous suspension preparations

a technology of aqueous suspension and preparation, which is applied in the direction of antibacterial agents, drug compositions, immunological disorders, etc., can solve the problems of unstable concentration of drugs in the aqueous suspension, difficulty in redispersion, and aqueous suspension, and achieve good redispersibility

Inactive Publication Date: 2003-10-16
SENJU PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

0007] The objective of the present invention is to ...

Problems solved by technology

Aqueous suspensions often have problems such as difficulty in redispersion due to aggregation of drug particles, formation of macro crystals from suspended particles or formation of secondary particles from deposited particles, any of which could take place during long-term storage or when they are exposed to temporary heating or fluctuation of temperature/humidity.
In addition, some types of suspended particles adhere to or get adsorbed by the walls of a plastic container and could thus cause a problem of unstable concentration of the drug contained in the aqueous suspensions.
However, while it is not possible to completely prevent sedimentation of suspended particles by reducing the size of the particles in the suspension and increasing the viscosity of the dispersion medium, ...

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0090] Eye Drops

7 Fluorometholone 0.1 g Sodium dihydrogen phosphate, dihydrate 0.1 g Sodium chloride 0.8 g Polyvinylpyrrolidone K25 0.5 g Sodium alginate 0.2 g Polysorbate 80 0.1 g Benzalkonium chloride 0.005 g Sodium hydroxide q.s. Purified water to 100 mL pH 7.0

[0091] Sodium dihydrogen phosphate, dihydrate, sodium chloride, polysorbate 80, polyvinylpyrrolidone K25, sodium alginate and benzalkonium chloride were added to about 80 mL of purified water and dissolved, and the pH was adjusted to 7 with sodium hydroxide. Fluorometholone then was added and homogeneously suspended with a homogenizer. Addition of purified water to make the total volume of 100 mL gave suspension-type eye drops containing fluorometholone.

example 2

[0092] Eye Drops

8 Indomethacin 0.5 g Sodium acetate 0.1 g Sodium chloride 0.8 g Polyvinylpyrrolidone K30 1.0 g Sodium alginate 0.5 g Methyl p-hydroxybenzoate 0.026 g Propyl p-hydroxybenzoate 0.014 g Hydrochloric acid q.s. Purified water to 100 mL pH 5.0

[0093] Sodium acetate, sodium chloride, polyvinylpyrrolidone K30, sodium alginate, methyl p-hydroxybenzoate and propyl p-hydroxybenzoate were added to about 80 mL of purified water and dissolved. Indomethacin then was added and homogeneously suspended with a homogenizer, and the pH was adjusted to 5 with hydrochloric acid. Addition of purified water to make the total volume of 100 mL gave suspension-type eye drops containing indomethacin.

example 3

[0094] Eye Drops

9 Pirenoxine 0.005 g Sodium acetate 0.1 g Sodium chloride 0.8 g Polyvinylpyrrolidone K30 1.0 g Sodium alginate 0.1 g Benzalkonium chloride 0.005 g Hydrochloric acid q.s. Purified water to 100 mL pH 4.0

[0095] Sodium acetate, sodium chloride, polyvinylpyrrolidone K30, sodium alginate and benzalkonium chloride were added to about 80 mL of purified water and dissolved. Pirenoxine then was added and homogeneously suspended with a homogenizer, and the pH was adjusted to 4 with hydrochloric acid. Addition of purified water to make the total volume of 100 mL gave suspension-type eye drops containing pirenoxine.

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Abstract

Addition of polyvinylpyrrolidone and a water-soluble anionic macromolecular compound to an aqueous suspension of a hardly soluble drug allows to provide an aqueous suspension in which aggregation of drug particles, formation of macro crystals from suspended particles and formation of secondary particles from deposited particles are prevented, and adhesion and adsorption to containers made of plastics, e.g., polypropylene or polyethylene, are avoided. As it has a good redispersibility, the aqueous suspension is useful as eye drops, nasal drops, ear drops, injections, oral preparations, liniments and lotions.

Description

[0001] The present invention relates to an aqueous suspension with good redispersibility comprising polyvinylpyrrolidone and a water-soluble anionic macromolecular compound which are added to prevent a hardly soluble drug from adhering to a container and forming aggregates.[0002] Aqueous suspensions often have problems such as difficulty in redispersion due to aggregation of drug particles, formation of macro crystals from suspended particles or formation of secondary particles from deposited particles, any of which could take place during long-term storage or when they are exposed to temporary heating or fluctuation of temperature / humidity. In addition, some types of suspended particles adhere to or get adsorbed by the walls of a plastic container and could thus cause a problem of unstable concentration of the drug contained in the aqueous suspensions.[0003] To address these problems, measures have been taken in order to prevent formation of secondary particles by blocking sediment...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K31/198A61K31/496A61K31/573A61K47/32A61K47/36A61K47/38A61P1/04A61P9/10A61P11/00A61P17/00A61P25/08A61P25/18A61P25/22A61P27/12A61P29/00A61P31/04A61P31/12A61P35/00A61P37/06
CPCA61K9/0014A61K9/0019A61K9/0043A61K9/0046A61K9/0048A61K47/38A61K31/496A61K31/573A61K47/32A61K47/36A61K31/198A61P1/04A61P9/10A61P11/00A61P17/00A61P25/08A61P25/18A61P25/22A61P27/12A61P29/00A61P31/04A61P31/12A61P35/00A61P37/06
Inventor SAWA, SHIROU
Owner SENJU PHARMA CO LTD
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