Title: Controlled drug releasing preparations

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Claims: Having now particularly described and ascertained the nature of our said invention and in what manner the same is to be performed, we declare that what we claim is:

1. A zero order release rate drug releasing preparation adapted for oral administration and for the controlled release of the drug contained therein at a substantially constant release rate during the first hour after administration and for several hours thereafter, which preparation comprises a drug body encapsulated in or coated with an outer solvent member, said drug body being selected from the group consisting of pure drug and drug admixed with an additional substance or substances which do not substantially influence the zero order release rate of the drug in said drug releasing preparation, and said solvent membrane comprising at least one plasticizer and at least one reinforcing polymer, which membrane is essentially insoluble in the digestive tract, the plasticizer content constituting from about 40 to about 90% by weight of the solvent membrane, said solvent membrane in the as prepared drug releasing preparation being substantially free of drug.

2. A drug releasing preparation according to claim 1, wherein plasicizer is 2-Ethyl-hexyl-diphenyl phosphate and the polymer reinforcing said plasticizer is polyvinyl chloride.

3. A drug releasing preparation according to claim 1, wherein the reinforcing polymer is a thermoplastic polymer.

4. A drug releasing preparation according to claim 3, wherein the polymer is selected from the group consisting of polyvinylchloride and polyvinylacetate.

5. A drug releasing preparation according to claim 1, wherein the plasticiser is selected from the group consisting of adipates, sebacates, phosphates and phthalates.

6. A drug releasing preparation according to claim 4 wherein the plasticiser is selected from the group consisting of butyl-phthalyl-butyl-glycolate, epoxidised soy bean oil, tritolyl-phosphate, dibutyl sebacate, dioctyl sebacate, tri-(diethyl-hexyl)-phosphate, 2-ethyl-hexyl-diphenyl phosphate, di-iso-butyl-adipate, methyl stearate, glycerol glyceryl monooleate, butyl-benzyl phthalate, dioctyl phthalate, diphenyl-octyl phosphate, diethyl phthalate, di-(2-ethyl-hexyl)-phthalate and TBP.

7. A drug releasing preparation according to claim 1, wherein the plasticiser content is at least about 80% by weight of the weight of the solvent membrane.

8. A drug releasing preparation according to claim 1, wherein the therapeutic agent is selected from the group consisting of steroids, vitamins, antihistamines, stimulants, tranquilizers. antibiotics and arrhytmic agents.

9. A drug releasing preparation according to claim 8, wherein the therapeutic agent is selected from the group consisting of digitalis, antipyrine, procainamide hydrochloride, atropine sulfate, theophylline and dicumarol, diazepam, amitriptyline and dehydroemetine.
Other info:

Inventors: Bloch, Rene (Savion, IL, US)
Kedem, Ora (Rehovoth, IL, US)
Lobel, Ester (Hulon, IL, US)

Application Number: 466018
Filing Date: 1974-05-01
Publication_date: 1976-06-22
Assignee: E. E. Eljim Ecology Ltd. (Rehovoth, IL)
Primary Class(es): 424/450 424/472
Other Classes:
US Patent Ref:

3318769	May, 1967	Folckemer et al.	424/78.
3325365	Jun, 1967	Hotko et al.	424/33.
3710795	Jan, 1973	Higuchi et al.	128/260.
3737521	Jun, 1973	Born	424/22.

Other Refs: 2,135,022

Jan, 1973	FR.

Primary Examiner: Rose, Shep K.
Assistant Examiner:
Attorney: Wallenstein, Spangenberg, Hattis & Strampel