Claims
- 1. The method of making a pharmaceutical dosage form which comprises the steps of
- (A) preparing a polymer dispersion by dispersing particles of a preformed dry powdered copolymer in an aqueous phase by stirring at an elevated temperature until no sediment forms when said dispersion is allowed to stand, whereby self-emulsifying dispersed particles smaller than said powder particles are formed, said aqueous medium consisting essentially of water or of water and a pharmaceutically acceptable plasticizer for said copolymer, said copolymer being a water swellable but water insoluble copolymer consisting essentially of
- (1) a monoethylenically unsaturated quaternary ammonium compound selected from the group consisting of N-vinyl pyridinium salts and quaternary aminoalkyl esters and quaternary aminoalkyl amides of acrylic acid of methacrylic acid of the formula ##STR2## wherein R is hydrogen or methyl;
- A is oxygen or --NH--;
- B is linear or branched alkyl or an alicyclic hydrocarbon;
- R.sub.1, R.sub.2, and R.sub.3, taken alone, are the same or different alkyl or aralkyl, or R.sub.1 and R.sub.2, taken together with the quaternary nitrogen atom, are piperidinium or morpholinium; and
- (2) at least one nonionic monomer, and
- (B) applying said polymer dispersion to a core comprising a pharmaceutically active substance and drying said dispersion.
- 2. A method for making a granulation of a pharmaceutically active powder which comprises the steps of
- (A) preparing a polymer dispersion by dispersing particles of a preformed dry powdered copolymer in an aqueous phase by stirring at an elevated temperature until no sediment forms when said dispersion is allowed to stand, whereby self-emulsifying dispersed particles smaller than said powder particles are formed, said aqueous medium consisting essentially of water or of water and a pharmaceutically acceptable plasticizer for said copolymer, said copolymer being a water swellable but water insoluble copolymer consisting essentially of
- (1) a monoethylenically unsaturated quaternary ammonium compound selected from the group consisting of n-vinyl pyridinium salts and quaternary aminoalkyl esters and quaternary aminoalkyl amides of acrylic acid or of methacrylic acid of the formula ##STR3## wherein R is hydrogen or methyl;
- A is oxygen or --NH--;
- B is linear or branched alkyl or an alicyclic hydrocarbon;
- R.sub.1, R.sub.2, and R.sub.3, taken alone, are the same or different alkyl or aralkyl, or R.sub.1 and R.sub.2, taken together with the quaternary nitrogen atom, are piperidinum or morpholinium; and
- (2) at least one nonionic monomer, and
- (B) coating said powder with said polymer dispersion and drying said dispersion.
- 3. The method for making a film layer having a therapeutically active substance embedded therein which comprises the steps of
- (A) preparing a polymer dispersion by dispersing particles of a preformed dry powdered copolymer in an aqueous phase by stirring at an elevated temperature until no sediment forms when said dispersion is allowed to stand, whereby self-emulsifying dispersed particles smaller than said powder particles are formed, said aqueous medium consisting essentially of water or of water and a pharmaceutically acceptable plasticizer for said copolymer, said copolymer being a water swellable but water insoluble copolymer consisting essentially of
- (1) a monoethylenically unsaturated quaternary ammonium compound selected from the group consisting of N-vinyl pyridinium salts and quaternary aminoalkyl esters and quaternary aminoalkyl amides of acrylic acid or of methacrylic acid of the formula ##STR4## wherein R is hydrogen or methyl;
- A is oxygen or --NH--;
- B is linear or branched alkyl or an alicyclic hydrocarbon;
- R.sub.1, R.sub.2, and R.sub.3, taken alone, are the same or different alkyl or aralkyl, or R.sub.1 and R.sub.2, taken together with the quaternary nitrogen atom, are piperidinum or morpholinium; and
- (2) at least one nonionic monomer, and
- (B) mixing said polymer dispersion with said active substance and drying said dispersion in the form of a layer.
Priority Claims (1)
Number |
Date |
Country |
Kind |
3438291 |
Oct 1984 |
DEX |
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Parent Case Info
This application is a continuation of application Ser. No. 937,430 filed Dec. 2, 1986 and now abandoned which in turn is a continuation of application Ser. No. 787,969 filed Oct. 16, 1985 and now abandoned.
US Referenced Citations (11)
Foreign Referenced Citations (4)
Number |
Date |
Country |
0058765 |
Sep 1982 |
EPX |
0088951 |
Sep 1983 |
EPX |
3208791 |
Mar 1971 |
DEX |
1617751 |
Jan 1985 |
DEX |
Continuations (2)
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Number |
Date |
Country |
Parent |
937430 |
Dec 1986 |
|
Parent |
787969 |
Oct 1985 |
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