EP0130683A2
Expired / Lapsed
EP
⏱️ 0.0 years remaining
N-Acetyl-p-aminophenol compositions containing partially gelatinized starch and method for preparing same
Assignee: Mallinckrodt Inc
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Filing: 1984-05-22
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Granted: —
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Expires: 2004-05-22
Abstract
Abstract An N-acetyl-p-aminophenol composition capable of being directly formed into a tablet having high hardness, short disintegration time and short dissolution time is disclosed. The composition includes N-acetyl-p-aminophenol, a pharmaceutically acceptable partially gelatinized starch, a pharmaceutically acceptable lubricant, water and optionally an auxiliary binder, an auxiliary disintegrant or both of these optional components. Also disclosed is a method for preparing the composition which includes forming a slurry containing the essential components (and optional components if desired) and spray drying the slurry.
Inventors
- 👤 Anil Manohar Salpekar
- 👤 Steven Robert Freebersyser
- 👤 Douglas Arthur Robinson
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-10-31 04:51
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/20; A61K9/2004; A61K9/2022; A61K9/205; A61K9/2059; A61K31/00; A61K31/16; A61K31/165; A61K9/2095; A61P; A61P25/00; A61P25/04
Claims Analysis
Total Claims: 13
Claim 1
Independent Claim
141 words
A direct tabletting, free-flowing particulate N-acetyl-p-aminophenol composition capable of being directly formed into a tablet having high hardness, short disintegration time, and short dissolution time, the composition comprising as components thereof: (A) N-acetyl-p-aminophenol, (B) a pharmaceutically acceptable partially gelatinized starch having a Percent Gelatinization of from about 50 to about 75% and in an amount effective for imparting said hardness, disintegration time and dissolution time, (C) a pharmaceutically acceptable lubricant in an amount at least sufficient to impart effective mold release properties to said tablet, and (D) water in an amount from about 0.5 to about 1.5% based on the total weight of the composition, said components being distributed throughout the particles of said composition in at least approximately the same distribution achieved when the composition is prepared by spray drying an aqueous slurry including said components (A), (B), and (C).
Claim 2
Dependent Claim
141 words
A direct tabletting, free-flowing particulate N-acetyl-p-aminophenol composition capable of being directly formed into a tablet having high hardness, short disintegration time, and short dissolution time, the composition comprising as components thereof: (A) N-acetyl-p-aminophenol, (B) a pharmaceutically acceptable partially gelatinized starch having a Percent Gelatinization of from about 50 to about 75% and in an amount effective for imparting said hardness, disintegration time and dissolution time, (C) a pharmaceutically acceptable lubricant in an amount at least sufficient to impart effective mold release properties to said tablet, and (D) water in an amount from about 0.5 to about 1.5% based on the total weight of the composition, said components being distributed throughout the particles of said composition in at least approximately the same distribution achieved when the composition is prepared by spray drying an aqueous slurry including said components (A), (B), and (C).
Claim 3
Dependent Claim
33 words
A composition according to claim 1, further including a pharmaceutically acceptable compressibility-promoting binder as an additional binding agent in an amount effective for increasing the obtainable hardness of tablets formed from the composition.
Claim 4
Dependent Claim
37 words
A composition according to claim 1 or claim 2, further including a pharmaceutically acceptable disintegration-promoting material as an additional disintegration agent in an amount effective for decreasing the obtainable disintegration time of tablets formed from the composition.
Claim 5
Dependent Claim
18 words
A composition according to any one of claims 1 to 3, wherein said Percent Gelatinization is about 60%.
Claim 6
Dependent Claim
36 words
A composition according to any one of claims 1 to 4, wherein said lubricant is stearic acid and is included in an amount of not more than 0.25% based on the total weight of the composition.
Claim 7
Dependent Claim
89 words
A composition according to any one of claims 1 to 5, including from about 93-83% by weight of N-acetyl-p-aminophenol; from about 5 to about 15% by weight of said partially gelatinized starch; from about 0.1 to about 0.4% by weight of stearic acid as said lubricant; from about 0.5 to about 1.4% by weight of polyvinylpyrrolidone as said additional binding agent; and from about 1 to about 5% by weight of cross-linked povidone as said additional disintegration agent; based on 100% by weight of the composition exclusive of water.
Claim 8
Dependent Claim
29 words
A composition according to claim 6, including about 90% N-acetyl-p-aminophenol; about 6.4% partially gelatinized starch; about 0.15% by weight stearic acid; about 1.2% polyvinylpyrrolidone and about 2.2% cross-linked povidone.
Claim 9
Dependent Claim
23 words
A composition according to any one of claims 1 to 7, wherein the composition is at least substantially free of fully gelatinized starch.
Claim 10
Independent Claim
177 words
A method for preparing a direct tabletting, free-flowing particulate N-acetyl-p-aminophenol composition capable of being directly formed into a tablet having high hardness, short disintegration time and short dissolution time, said method comprising: (A) forming a slurry containing components dispersed substantially uniformly throughout an aqueous medium, said components comprising: (A) N-acetyl-p-aminophenol, (B) a pharmaceutically acceptable partially gelatinized starch having a Percent Gelatinization of from about 50 to about 75% and in an amount effective for imparting said hardness, disintegration time and dissolution time, (C) a pharmaceutically acceptable lubricant in an amount at least sufficient to impart effective mold release properties to said tablet, (B) spray drying said slurry under spray drying conditions such that the spray dried particles include water in an amount from about 0.5 to about 1.5% based on the total weight of the composition, said components being distributed throughout the particles of said composition such that at least a portion of said lubricant is dispersed within said particles and at least a portion of the lubricant is disposed on the outer surfaces of said particles.
Claim 11
Independent Claim
177 words
A method for preparing a direct tabletting, free-flowing particulate N-acetyl-p-aminophenol composition capable of being directly formed into a tablet having high hardness, short disintegration time and short dissolution time, said method comprising: (A) forming a slurry containing components dispersed substantially uniformly throughout an aqueous medium, said components comprising: (A) N-acetyl-p-aminophenol, (B) a pharmaceutically acceptable partially gelatinized starch having a Percent Gelatinization of from about 50 to about 75% and in an amount effective for imparting said hardness, disintegration time and dissolution time, (C) a pharmaceutically acceptable lubricant in an amount at least sufficient to impart effective mold release properties to said tablet, (B) spray drying said slurry under spray drying conditions such that the spray dried particles include water in an amount from about 0.5 to about 1.5% based on the total weight of the composition, said components being distributed throughout the particles of said composition such that at least a portion of said lubricant is dispersed within said particles and at least a portion of the lubricant is disposed on the outer surfaces of said particles.
Claim 12
Dependent Claim
31 words
A method according to claim 9, wherein the slurry is formed and maintained under forming and maintaining conditions including sufficiently low shear to avoid increasing said Percent Gelatinization above about 75%.
Claim 13
Dependent Claim
26 words
A tablet formed from a composition according to any one of claims 1 to 8 or by a method according to claim 9 or claim 10.
References Cited (Backward Citations)
No citation records indexed.
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