US4132753A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Process for preparing oral sustained release granules
Assignee: Wyeth Holdings LLC
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Filing: 1967-11-03
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Granted: 1979-01-02
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Expires: 1987-11-03
Abstract
Abstract This disclosure relates to the process of preparing granules of controlled release medicament by continually agitating a mixture of powdered medicament and finely divided wax-like material while subjecting the mixture to radiation heating.
Inventors
- 👤 Mitchell S. Blichare
- 👤 Gerald J. Jackson, Jr.
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 07:37
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/14; A61K9/16; A61K9/1682; A61K9/1694; A61K9/1605; A61K9/1617; B; B01; B01J; B01J2/00; B01J2/003
Claims Analysis
Total Claims: 17
Claim 1
Independent Claim
120 words
A process of preparing granules of controlled release medicament which comprises: continuously agitating a mixture of (a) powdered medicament and (b) finely divided wax-like material having a melting point between about 30° C and 100° C, while subjecting the mixture to radiation heating at a temperature sufficiently high that the medicament powder has a temperature higher than the melting point of the wax-like material, the temperature of the medicament powder also being higher than the actual temperature of the wax-like material, whereby the hotter medicament powder sinks into the molten surfaces of the wax-like material to form granules comprising medicament powder and wax-like material; and cooling, lubricating, and sizing the resulting granules to sizes between about 12 and 60 mesh.
Claim 2
Dependent Claim
120 words
A process of preparing granules of controlled release medicament which comprises: continuously agitating a mixture of (a) powdered medicament and (b) finely divided wax-like material having a melting point between about 30° C and 100° C, while subjecting the mixture to radiation heating at a temperature sufficiently high that the medicament powder has a temperature higher than the melting point of the wax-like material, the temperature of the medicament powder also being higher than the actual temperature of the wax-like material, whereby the hotter medicament powder sinks into the molten surfaces of the wax-like material to form granules comprising medicament powder and wax-like material; and cooling, lubricating, and sizing the resulting granules to sizes between about 12 and 60 mesh.
Claim 3
Dependent Claim
50 words
The process of claim 1 in which the finely divided wax-like material is selected from the group consisting of glyceryl monostearate, hydrogenated tallow, castor wax, myristyl alcohol, white beeswax, myristic acid, stearyl alcohol, substituted monoglycerides, substituted diglycerides, substituted triglycerides, carnauba wax, acetylated monoglycerides, stearic acid, polyethylene glycols and mixtures thereof.
Claim 4
Dependent Claim
13 words
The process of claim 2 in which the wax-like material is glyceryl monostearate.
Claim 5
Dependent Claim
14 words
The process of claim 2 in which the wax-like material is a hydrogenated fat.
Claim 6
Dependent Claim
15 words
The process of claim 2 in which the wax-like material is a waxy aliphatic alcohol.
Claim 7
Dependent Claim
12 words
The process of claim 1 in which the medicament is ferrous fumarate.
Claim 8
Dependent Claim
11 words
The process of claim 1 in which the medicament is meprobamate.
Claim 9
Dependent Claim
11 words
The process of claim 1 in which the medicament is phenobarbital.
Claim 10
Dependent Claim
11 words
The process of claim 1 in which the medicament is acetazolamide.
Claim 11
Dependent Claim
35 words
The process of claim 1 in which the medicament powder is preheated to a temperature above the melting point of the wax-like material, and the hot medicament powder is then mixed with the wax-like material.
Claim 12
Dependent Claim
32 words
The process of claim 10 in which the wax-like material is also preheated to a temperature above room temperature but below its melting temperature before it is mixed with the powdered medicament.
Claim 13
Dependent Claim
63 words
The process of claim 1 in which the powder and wax-like material are at substantially the same temperature when they are mixed, this temperature being below the melting point of the wax-like material, and in which the radiation heating of the mixture is continued until the temperature of the powder is at least 6-8° C above the melting point of the wax-like material.
Claim 14
Dependent Claim
108 words
A continuous process according to claim 1 in which the medicament and wax-like material are introduced into one end of a rotating tumbling cylinder and subjected to infrared radiation heating inside said cylinder for a period of time to form spherical granules at a final temperature above the melting point of the wax-like material but insufficiently high to cause the granules to adhere to each other while being tumbled; and the granules are dispersed into a second rotating cylinder having a cool air exhaust system and cooled therein to a temperature below the melting point of the wax-like material, while being maintained in a state of continuous agitation.
Claim 15
Dependent Claim
108 words
A continuous process according to claim 12 in which the medicament and wax-like material are introduced into one end of a rotating tumbling cylinder and subjected to infrared radiation heating inside said cylinder for a period of time to form spherical granules at a final temperature above the melting point of the wax-like material, but insufficiently high to cause the granules to adhere to each other while being tumbled; and the granules are dispersed into a second rotating cylinder having a cool air exhaust system and cooled therein to a temperature below the melting point of the wax-like material, while being maintained in a state of continuous agitation.
Claim 16
Dependent Claim
108 words
A continuous process according to claim 10 in which the medicament and wax-like material are introduced into one end of a rotating tumbling cylinder and subjected to infrared radiation heating inside said cylinder for a period of time to form spherical granules at a final temperature above the melting point of the wax-like material but insufficiently high to cause the granules to adhere to each other while being tumbled; and the granules are dispersed into a second rotating cylinder having a cool air exhaust system and cooled therein to a temperature below the melting point of the wax-like material, while being maintained in a state of continuous agitation.
Claim 17
Dependent Claim
108 words
A continuous process according to claim 11 in which the medicament and wax-like material are introduced into one end of a rotating tumbling cylinder and subjected to infrared radiation heating inside said cylinder for a period of time to form spherical granules at a final temperature above the melting point of the wax-like material but insufficiently high to cause the granules to adhere to each other while being tumbled; and the granules are dispersed into a second rotating cylinder having a cool air exhaust system and cooled therein to a temperature below the melting point of the wax-like material, while being maintained in a state of continuous agitation.
References Cited (Backward Citations)
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1982-01-01 | 1982-07-03 | 1983-01-02 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1986-01-01 | 1986-07-03 | 1987-01-02 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1990-01-01 | 1990-07-03 | 1991-01-02 | $7700.00 | Window Closed / Lapsed |