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EP0205282A2
Expired / Lapsed
EP
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Oral pharmaceutical composition
Assignee: Euro Celtique SA
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Filing: 1986-05-28
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Granted: —
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Expires: 2006-05-28
Abstract
Abstract A sustained release, oral pharmaceutical composition in solid unit dosage form, for application to the mucosa of the oral or nasal cavity, comprises compressed, mucosa adhesive cellulose, coated granules, the granules comprising a drug, a higher aliphatic alcohol and a hydrated water soluble hydroxyalkyl cellulose. Preferably the composition is in the form of a buccal tablet, especially a kidney shaped buccal tablet. Preferred materials are morphine as the drug, hydroxypropyl cellulose as the mucosa adhesive cellulose, cetostearyl alcohol as the aliphatic alcohol and hydroxyethyl cellulose as the water soluble cellulose. The composition has enhanced adherent properties (to the mucosa) and prolongs the bioavailability of the drug.
Inventors
- 👤 Anthony William Jenkins
- 👤 Stewart Thomas Leslie
- 👤 Ronald Brown Miller
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-11-04 07:05
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/20; A61K9/14; A61K9/16; A61K9/1605; A61K9/1629; A61K9/1652; A61K9/0012; A61K9/0053; A61K9/006; A61K9/1617; A61K9/2095; A61K9/48; A61K9/50; A61K9/5005; A61K9/5021; A61K9/5036; A61K9/5042; A61K9/5047
Claims Analysis
Total Claims: 34
Claim 1
Independent Claim
57 words
A sustained release, oral pharmaceutical composition in solid unit dosage form, for application to the mucosa of the oral or nasal cavity, comprising compressed granules characterised in that the granules comprise a drug, a higher aliphatic alcohol and a hydrated water soluble hydroxyalkyl cellulose and further in that the granules are coated with a mucosa adhesive cellulose.
Claim 2
Dependent Claim
57 words
A sustained release, oral pharmaceutical composition in solid unit dosage form, for application to the mucosa of the oral or nasal cavity, comprising compressed granules characterised in that the granules comprise a drug, a higher aliphatic alcohol and a hydrated water soluble hydroxyalkyl cellulose and further in that the granules are coated with a mucosa adhesive cellulose.
Claim 3
Dependent Claim
19 words
A composition according to claim 1 characterised in that the granules are coated with a powdered mucosa adhesive cellulose.
Claim 4
Dependent Claim
34 words
A composition according to either claim 1 or claim 2 characterised in that the mucosa adhesive cellulose comprises a carboxyalkyl cellulose or a hydroxyalkyl cellulose, preferably sodium carboxymethyl cellulose, hydroxypropylmethyl cellulose or hydroxypropyl cellulose.
Claim 5
Dependent Claim
16 words
A composition according to claim 3 characterised in that the mucosa adhesive cellulose comprises hydroxypropyl cellulose.
Claim 6
Dependent Claim
38 words
A composition according to any one of claims 1 to 4 characterised in that the mucosa adhesive cellulose coating comprises between 2% and 15% (w/w), especially between 4% and 10% - (w/w), of the total dosage form weight.
Claim 7
Dependent Claim
24 words
A composition according to any one of claims 1 to 5 characterised in that the higher aliphatic alcohol comprises cetyl alcohol or cetostearyl alcohol.
Claim 8
Dependent Claim
37 words
A composition according to any one of claims 1 to 6 characterised in that the higher aliphatic alcohol comprises between 5% and 35% - (w/w), especially between 10% and 30% (w/w), of the total dosage form weight.
Claim 9
Dependent Claim
33 words
A composition according to any one of claims 1 to 7 characterised in that the water soluble hydroxyalkyl cellulose comprises hydroxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose or hydroxypropylmethyl cellulose, . preferably hydroxyethyl cellulose.
Claim 10
Dependent Claim
31 words
A composition according to any one of claims 1 to 8 characterised in that the water soluble hydroxyalkyl cellulose comprises between 2% and 15% (w/w), of the total dosage form weight.
Claim 11
Dependent Claim
25 words
A composition according to any one of claims 1 to 9 characterised in that the drug comprises morphine, nifedipine, phenazocine, verapamil or salbutamol, preferably morphine.
Claim 12
Dependent Claim
49 words
A composition according to any one of claims 1 to 10 characterised in that the granules further comprise between 2% and 15% (w/w), especially between 4% and 10% (w/w), of a binder comprising a carboxyalkyl cellulose or a hydroxyalkyl cellulose, preferably sodium carboxymethyl cellulose, hydroxypropylmethyl cellulose or hydroxypropyl cellulose.
Claim 13
Dependent Claim
14 words
A composition according to claim 11 characterised in that the binder comprises hydroxypropyl cellulose.
Claim 14
Dependent Claim
21 words
A kidney shaped oral vehicle comprising a sustained release, oral pharmaceutical composition according to any one of claims 1 to 12.
Claim 15
Dependent Claim
20 words
14? A buccal tablet comprising a sustained release, oral pharmaceutical composition according to any one of claims 1 to 12.
Claim 16
Dependent Claim
72 words
A process for the preparation of a sustained release, oral pharmaceutical composition in solid unit dosage form, the composition being adapted for application to the mucosa of the oral or nasal cavity, comprising forming granules comprising a drug, a higher aliphatic alcohol and a hydrated water soluble hydroxyalkyl cellulose coating the granules with a mucosa adhesive cellulose, and compressing the mucosa adhesive cellulose coated granules to give a solid unit dosage form.
Claim 17
Dependent Claim
72 words
A process for the preparation of a sustained release, oral pharmaceutical composition in solid unit dosage form, the composition being adapted for application to the mucosa of the oral or nasal cavity, comprising forming granules comprising a drug, a higher aliphatic alcohol and a hydrated water soluble hydroxyalkyl cellulose coating the granules with a mucosa adhesive cellulose, and compressing the mucosa adhesive cellulose coated granules to give a solid unit dosage form.
Claim 18
Dependent Claim
81 words
A process according to claim 15 characterised in that the granules are formed by a process comprising mixing the drug, the water soluble hydroxyalkyl cellulose and, preferably, a binder comprising a carboxyalkyl cellulose or a hydroxyalkyl cellulose to form a drug containing mixture, hydrating the drug containing mixture to form a wet granular mass, drying the wet granular mass to form a dry granular mass, and mixing the dry granular mass with a higher aliphatic alcohol; Claims for contracting state AT
Claim 19
Dependent Claim
72 words
A process for the preparation of a sustained release, oral pharmaceutical composition in solid unit dosage form, the composition being adapted for application to the mucosa of the oral or nasal cavity, comprising forming granules comprising a drug, a higher aliphatic alcohol and a hydrated water soluble hydroxyalkyl cellulose, coating the granules, with a mucosa adhesive cellulose, and compressing the mucosa adhesive cellulose, coated granules to give a solid unit dosage form.
Claim 20
Dependent Claim
72 words
A process for the preparation of a sustained release, oral pharmaceutical composition in solid unit dosage form, the composition being adapted for application to the mucosa of the oral or nasal cavity, comprising forming granules comprising a drug, a higher aliphatic alcohol and a hydrated water soluble hydroxyalkyl cellulose, coating the granules, with a mucosa adhesive cellulose, and compressing the mucosa adhesive cellulose, coated granules to give a solid unit dosage form.
Claim 21
Dependent Claim
19 words
A process according to claim 1 characterised in that the granules are coated with a powdered mucosa adhesive cellulose.
Claim 22
Dependent Claim
34 words
A process according to either claim 1 or claim 2 characterised in that the mucosa adhesive cellulose comprises a carboxyalkyl cellulose or a hydroxyalkyl cellulose, preferably sodium carboxymethyl cellulose, hydroxypropylmethyl cellulose or hydroxypropyl cellulose.
Claim 23
Dependent Claim
16 words
A process according to claim 3 characterised in that the mucosa adhesive cellulose comprises hydroxypropyl cellulose.
Claim 24
Dependent Claim
37 words
A process according to any one of claims 1 to 4 characterised in that the mucosa adhesive cellulose coating comprises between 2% and 15% (wiw), especially between 4% and 10% (w/w), of the total dosage form weight.
Claim 25
Dependent Claim
24 words
A process according to any one of claims 1 to 5 characterised in that the higher aliphatic alcohol comprises cetyl alcohol or cetostearyl alcohol.
Claim 26
Dependent Claim
36 words
A process according to any one of claims 1 to 6 characterised in that the higher aliphatic alcohol comprises between 5% and 35% (w/w), especially between 10% and 30% (w/w), of the total dosage form weight.
Claim 27
Dependent Claim
32 words
A process according to any one of claims 1 to 7 characterised in that the water soluble hydroxyalkyl cellulose comprises hydroxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose or hydroxypropylmethyl cellulose, preferably hydroxyethyl cellulose.
Claim 28
Dependent Claim
32 words
A process according to any one of claims 1 to 8 characterised in that the water soluble hydroxyalkyl cellulose comprises between 2% and 15% - (w/w), of the total dosage form weight.
Claim 29
Dependent Claim
25 words
A process according to any one of claims 1 to 9 characterised in that the drug comprises morphine, nifedipine, phenazocine, verapamil or salbutamol, preferably morphine.
Claim 30
Dependent Claim
49 words
A process according to any one of claims 1 to 10 characterised in that the granules further comprise between 2% and 15% (w/w), especially between 4% and 10% (w/w), of a binder comprising a carboxyalkyl cellulose or a hydroxyalkyl cellulose, preferably sodium carboxymethyl cellulose, hydroxypropylmethyl cellulose or hydroxypropyl cellulose.
Claim 31
Dependent Claim
14 words
A process according to claim 11 characterised in that the binder comprises hydroxypropyl cellulose.
Claim 32
Dependent Claim
81 words
A process according to any one of claims 1 to 12 characterised in that the granules are formed by a process comprising mixing the drug, the water soluble hydroxyalkyl cellulose and, preferably, a binder comprising a carboxyalkyl cellulose or a hydroxyalkyl cellulose to form a drug containing mixture, hydrating the drug containing mixture to form a wet granular mass, drying the wet granular mass to form a dry granular mass, and mixing the dry granular mass with a higher aliphatic alcohol.
Claim 33
Dependent Claim
29 words
A process according to any one of claims 1 to 13 characterised in that the mucosa adhesive cellulose, coated granules are compressed to give a kidney shaped oral vehicle.
Claim 34
Dependent Claim
27 words
A process according to any one of claims 1 to 13 characterised in that the mucosa adhesive cellulose, coated granules are compressed to give a buccal tablet.
References Cited (Backward Citations)
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