US4518433A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Enteric coating for pharmaceutical dosage forms
Assignee: FMC Corp
•
Filing: 1982-11-08
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Granted: 1985-05-21
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Expires: 2002-11-08
Abstract
Abstract The application discloses a process for making a polymeric powder which is readily dispersible in water to provide a composition useful for forming an enteric coating on pharmaceutical dosage forms and also a process for using the powder for its intended purpose.
Inventors
- 👤 Emanuel J. McGinley
- 👤 Domingo C. Tuason, Jr.
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-29 09:35
CPC Classifications
C; C08; C08J; C08J3/00; C08J3/12; C08J3/122; A; A61; A61K; A61K9/00; A61K9/20; A61K9/28; A61K9/2806; A61K9/2833; A61K9/286; A61K9/2866; C08J2301/00; C08J2301/08; C08J2301/14
Claims Analysis
Total Claims: 26
Claim 1
Independent Claim
111 words
A process of making a polymeric powder which is readily dispersible in water to provide a composition useful for forming an enteric coating on pharmaceutical dosage forms, comprising providing a freshly prepared aqueous dispersion of a water-insoluble enteric polymer, adding to said dispersion an acetylated monoglyceride characterized by being liquid at room temperature and having a degree of acetylation of at least about 96%, said acetylated monoglyceride being added in an amount of between about 6% and about 18% based upon the weight of the dry insoluble solids contained in the dispersion, thoroughly mixing to distribute the acetylated monoglyceride throughout the dispersion, and homogenizing and spray drying to form the powder.
Claim 2
Dependent Claim
111 words
A process of making a polymeric powder which is readily dispersible in water to provide a composition useful for forming an enteric coating on pharmaceutical dosage forms, comprising providing a freshly prepared aqueous dispersion of a water-insoluble enteric polymer, adding to said dispersion an acetylated monoglyceride characterized by being liquid at room temperature and having a degree of acetylation of at least about 96%, said acetylated monoglyceride being added in an amount of between about 6% and about 18% based upon the weight of the dry insoluble solids contained in the dispersion, thoroughly mixing to distribute the acetylated monoglyceride throughout the dispersion, and homogenizing and spray drying to form the powder.
Claim 3
Dependent Claim
36 words
The process set forth in claim 1 wherein the acetylated monoglyceride is added in an amount of between about 10% and about 14% based upon the weight of the dry insoluble solids contained in the dispersion.
Claim 4
Dependent Claim
21 words
The process set forth in claim 1 wherein the acetylated monoglyceride is pre-emulsified in water before being added to the dispersion.
Claim 5
Dependent Claim
24 words
The process set forth in claim 1 wherein said freshly prepared aqueous dispersion comprises substantially spherical particles predominately of a diameter below 5 μm.
Claim 6
Dependent Claim
20 words
The process set forth in claim 4 wherein said spherical particles predominately have a diameter between 0.2 and 0.5 μm.
Claim 7
Dependent Claim
37 words
The process set forth in claim 4 wherein the spray dried powder consists of aggregates of particles capable of being reconstituted to near the original size of the solid particles contained in the freshly prepared aqueous dispersion.
Claim 8
Dependent Claim
48 words
The process set forth in claim 6 comprising the additional steps of dispersing the spray dried powder in water, adding a plasticizer in an amount of between 10% and 40% of the weight of the polymer to form a coating composition and coating a pharmaceutical dosage form therewith.
Claim 9
Dependent Claim
12 words
A polymeric powder made by the process set forth in claim 1.
Claim 10
Dependent Claim
110 words
A process of making a polymeric powder which is readily dispersible in water to provide a composition useful for forming an enteric coating on pharmaceutical dosage forms, comprising providing a freshly prepared aqueous dispersion of cellulose acetate phthalate, adding to said dispersion an acetylated monoglyceride characterized by being liquid at room temperature and having a degree of acetylation of at least about 96%, said acetylated monoglyceride being added in an amount of between about 6% and about 18% based upon the weight of the dry insoluble solids contained in the dispersion, thoroughly mixing to distribute the acetylated monoglyceride throughout the dispersion, and homogenizing and spray drying to form the powder.
Claim 11
Dependent Claim
110 words
A process of making a polymeric powder which is readily dispersible in water to provide a composition useful for forming an enteric coating on pharmaceutical dosage forms, comprising providing a freshly prepared aqueous dispersion of cellulose acetate phthalate, adding to said dispersion an acetylated monoglyceride characterized by being liquid at room temperature and having a degree of acetylation of at least about 96%, said acetylated monoglyceride being added in an amount of between about 6% and about 18% based upon the weight of the dry insoluble solids contained in the dispersion, thoroughly mixing to distribute the acetylated monoglyceride throughout the dispersion, and homogenizing and spray drying to form the powder.
Claim 12
Dependent Claim
36 words
The process set forth in claim 9 wherein the acetylated monoglyceride is added in an amount of between about 10% and about 14% based upon the weight of the dry insoluble solids contained in the dispersion.
Claim 13
Dependent Claim
21 words
The process set forth in claim 9 wherein the acetylated monoglyceride is pre-emulsified in water before being added to the dispersion.
Claim 14
Dependent Claim
24 words
The process set forth in claim 9 wherein said freshly prepared aqueous dispersion comprises substantially spherical particles predominately of a diameter below 0.5 μm.
Claim 15
Dependent Claim
20 words
The process set forth in claim 12 wherein said spherical particles predominately have a diameter between 0.2 and 0.5 μm.
Claim 16
Dependent Claim
37 words
The process set forth in claim 12 wherein the spray dried powder consists of aggregates of particles capable of being reconstituted to near the original size of the solid particles contained in the freshly prepared aqueous dispersion.
Claim 17
Dependent Claim
51 words
The process set forth in claim 14 comprising the additional steps of dispersing the spray dried powder in water in the presence of a plasticizer in an amount of between 10% and 40% of the weight of the polymer to form a coating composition, and coating a pharmaceutical dosage form therewith.
Claim 18
Dependent Claim
12 words
A polymeric powder made by the process set forth in claim 9.
Claim 19
Dependent Claim
74 words
A polymeric powder capable of being readily dispersed in water to provide with the addition of a plasticizer a composition useful for forming an enteric coating on pharmaceutical dosage forms, said powder consisting essentially of a water-insoluble enteric polymer in the form of spherical polymer particles held together in aggregates and impregnated by an acetylated monoglyceride characterized by being liquid at room temperature and having a degree of acetylation of at least about 96%.
Claim 20
Dependent Claim
74 words
A polymeric powder capable of being readily dispersed in water to provide with the addition of a plasticizer a composition useful for forming an enteric coating on pharmaceutical dosage forms, said powder consisting essentially of a water-insoluble enteric polymer in the form of spherical polymer particles held together in aggregates and impregnated by an acetylated monoglyceride characterized by being liquid at room temperature and having a degree of acetylation of at least about 96%.
Claim 21
Dependent Claim
26 words
The polymeric powder set forth in claim 17 wherein said aggregates are capable of being reconstituted into polymer particles of a diameter less than 5.0 μm.
Claim 22
Dependent Claim
20 words
The polymeric powder set forth in claim 18 wherein said polymer particles are predominately of a diameter below 1.0 μm.
Claim 23
Dependent Claim
70 words
A polymeric powder capable of being readily dispersed in water to provide with the addition of a plasticizer a composition useful for forming an enteric coating on pharmaceutical dosage forms, said powder consisting essentially of substantially spherical particles of cellulose acetate phthalate held together in aggregates and impregnated by an acetylated monoglyceride characterized by being liquid at room temperature and having a degree of acetylation of at least about 96%.
Claim 24
Dependent Claim
70 words
A polymeric powder capable of being readily dispersed in water to provide with the addition of a plasticizer a composition useful for forming an enteric coating on pharmaceutical dosage forms, said powder consisting essentially of substantially spherical particles of cellulose acetate phthalate held together in aggregates and impregnated by an acetylated monoglyceride characterized by being liquid at room temperature and having a degree of acetylation of at least about 96%.
Claim 25
Dependent Claim
21 words
The polymeric powder set forth in claim 20 wherein said polymer particles are predominately of a diameter less than 1.0 μm.
Claim 26
Dependent Claim
22 words
The polymeric powder set forth in claim 21 wherein said polymer particles are predominately of a diameter between 0.2 and 0.5 μm.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1988-05-20 | 1988-11-19 | 1989-05-21 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1992-05-20 | 1992-11-19 | 1993-05-21 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1996-05-20 | 1996-11-19 | 1997-05-21 | $7700.00 | Window Closed / Lapsed |