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Claims for Patent: 4,140,756

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Claims for Patent: 4,140,756

Title: Film-coated matrix core tablet
Abstract:A tablet for controlled release of a water soluble medicament or dietary supplement is comprised of a water insoluble wax-like matrix core containing the water soluble medicament and coated with a permeable erosion resistant polymeric film. The core constitutes 95% or more of the tablet weight.
Inventor(s): Gallian; Claude E. (Evansville, IN)
Assignee: Mead Johnson & Company (Evansville, IN)
Application Number:05/843,196
Patent Claims: 1. A pharmaceutical tablet for continuous release of a medicament during a predetermined dissolution period of at least 5 hrs. and up to 8 hrs. following ingestion by a mammal comprising a core constituting at least 95% of the tablet weight and containing at least 0.75 g. of a water soluble medicament and coated with a permeable erosion resistant polymeric film, said core comprising a compressed granulation containing from 72% to 85% by weight of said core of said water soluble medicament and from 13% to 25% by weight of said core of a water insoluble material having a wax-like consistency said film being continuous and constituting up to 5% of the tablet weight and being comprised of a major proportion of a polymeric material and a minor proportion of a plasticiser therefor wherein said polymeric material, said plasticiser, and the quantities thereof are selected so that said film remains intact for at least a portion of said dissolution period and confers a dissolution profile upon said tablet when measured by the rolling bottle method and expressed as percent by weight of medicament contained in said tablet dissolved per unit of time of from 45 to 75% during the first 3 hours of said dissolution period, a maximum of 25% during the first hour of said dissolution period, at least 66% during the first 5 hours, and at least 90% during the entire 8 hour dissolution period, the amount of medicament dissolved during the first hour of said dissolution period deviating by no more than 22% from the average hourly amount thereof dissolved during the first 3 hours of said dissolution period, and wherein the amount of medicament dissolved during the first hour of said dissolution period from said core in the absence of said film and measured by the rolling bottle method exceeds the average hourly amount thereof dissolved during the first 3 hours of said dissolution period by more than 22%.

2. The tablet of claim 1 wherein said water soluble medicament is potassium chloride.

3. The tablet of claim 1 wherein said water soluble medicament is sodium chloride.

4. The tablet of claim 1 wherein said water insoluble material having a wax-like consistency is stearic acid.

5. The tablet of claim 1 wherein said core constitutes approximately 97% of the tablet weight and said film constitutes approximately 3% of the tablet weight.

6. The tablet of claim 1 wherein said polymeric material is a mixture of hydroxypropyl methyl cellulose and ethyl cellulose.

7. The tablet of claim 1 wherein said polymeric material is a mixture of hydroxypropyl methyl cellulose and ethyl cellulose and said plasticiser is glycerol.

8. The tablet of claim 1 wherein said film contains 9 parts by weight of said polymeric material and 1 part by weight of said plasticiser.

9. The tablet of claim 1 wherein said film contains 5 parts by weight of hydroxypropyl methyl cellulose, 4 parts by weight of ethyl cellulose and 1 part by weight of glycerol.

10. The tablet of claim 1 wherein said film is enclosed within a decorative finish coat, said finish coat being readily erodible from said tablet during said dissolution period.

11. The tablet of claim 1 wherein said core contains at least 0.9 g. of said water soluble medicament.

12. A pharmaceutical tablet for oral potassium treatment by continuous release of potassium chloride during a dissolution period of at least 5 hrs. and up to 8 hrs. following ingestion by a mammal comprising a compressed core coated with a permeable erosion resistent polymeric film, said core containing 937.5 mg. of potassium chloride, 187.5 mg. of stearic acid, and from 20 to 100 mg. of pharmaceutical ingredients selected from the group consisting of lubricants, excipients, binders, and colors, said film being continuous and constituting up to 5% of the tablet weight and being comprised of sufficient of a homogeneous mixture of 5 parts by weight of hydroxypropyl methyl cellulose, 4 parts by weight of ethyl cellulose and 1 part by weight of glycerol to confer a dissolution profile upon said tablet when measured by the rolling bottle method and expressed as percent by weight of potassium chloride contained in said tablet dissolved per unit of time of from 45-75% during the first 3 hours of said dissolution period, a maximum of 25% during the first hour of said dissolution period, at least 66% during the first 5 hrs., and at least 90% during the entire 8-hour dissolution period, the amount of potassium chloride dissolved during the first hour of said dissolution period deviating by no more than 22% from the average hourly amount thereof dissolved during the first 3 hrs. of said dissolution period.

13. The tablet of claim 12 wherein said film is enclosed within a decorative finish coat, said finish coat being erodible from said tablet during said dissolution period at a sufficiently rapid rate as to not materially affect the dissolution profile specified in claim 12.

14. The tablet of claim 12 wherein said decorative coat is comprised of hydroxypropyl methyl cellulose containing opacifiers.

15. The tablet of claim 12 wherein said decorative coat is comprised of about 1.5 mg. of hydroxypropyl methyl cellulose having dispersed therein of an approximately equal weight of silicon dioxide.

16. A pharmaceutical tablet for oral potassium treatment by continuous release of potassium chloride during a dissolution period of at least 5 hrs. and up to 8 hrs. following ingestion by a mammal comprising a compressed core coated with a permeable erosion resistent polymeric film, said core containing 750 mg. of potassium chloride, 150 mg. of stearic acid, and from 16 to 80 mg. of pharmaceutical ingredients selected from the group consisting of lubricants, excipients, binders, and colors, said film being continuous and constituting about 3.6% of the tablet weight and being comprised of a homogeneous mixture of 5 parts by weight of hydroxypropyl methyl cellulose, 4 parts by weight of ethyl cellulose and 1 part by weight of glycerol wherein the dissolution profile of said tablet when measured by the rolling bottle method and expressed as percent by weight of potassium chloride contained in said tablet dissolved per unit of time is from 45-75% during the first 3 hours of said dissolution period, a maximum of 25% during the first hour of said dissolution period, at least 66% during the first 5 hrs. of said dissolution period, and at least 90% during the entire 8-hour dissolution period, the amount of potassium chloride dissolved during the first hour of said dissolution period deviating by no more than 22% from the average hourly amount thereof dissolved during the first 3 hrs. of said dissolution period.

17. The tablet of claim 16 wherein said film is enclosed within a decorative finish coat, said finish coat being erodible from said tablet during said dissolution period at a sufficiently rapid rate as to not materially affect the dissolution profile specified in claim 16.

18. The tablet of claim 16 wherein said decorative coat is comprised of hydroxypropyl methyl cellulose containing opacifiers.

19. The tablet of claim 16 wherein said decorative coat is comprised of about 1.4 mg. of hydroxypropyl methyl cellulose having dispersed therein of an approximately equal weight of silicon dioxide.
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