Pharmaceutical compositions containing hollow fine tubular drug delivery systems

• US 4,673,565 A
• Filed: 05/03/1985
• Issued: 06/16/1987
• Est. Priority Date: 05/03/1985
• Status: Expired due to Term

• Current Assignee: Bristol-Myers Squibb Pharma Company (Bristol-Myers Squibb Company)
• Original Assignee: E. I. du Pont de Nemours and Company (Corteva, Inc.)
• Inventors: Di Luccio, Robert C., Shefter, Eli, Duggins, Ray B.
• Primary Examiner(s): GRIFFIN, RONALD
• Application Number:
  US06/730,064
• Time in Patent Office: 774 Days
• Field of Search: 424/22, 424/15, 424/33, 514/965
• US Class Current: 424/443
• CPC Class Codes: A61K 9/0092 Hollow drug-filled fibres, tubes of the core-shell type, coated fibres, coated rods, microtubules or nanotubes
• CPC Class Codes: A61K 9/70 Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug hollow drug-filled fibres A61K9/0092

Abstract

Pharmaceutical compositions are provided which contain hollow fine tube drug delivery systems. The compositions comprise a pharmaceutically suitable carrier, preferably in the form of a capsule, tablet, suspension, or suppository, and at least one drug delivery system which consists essentially of (1) a polymeric tube having a membrane outer sheath and a hollow core, and (2) at least one drug compound contained within the core, said system contained in the composition in an amount sufficient to deliver a therapeutic amount of the drug contained therein at a predetermined rate over a predetermined period of time. By varying the polymer, the permeability of the outer sheath, the drug, the drug concentration in the hollow core of the tube, the tube diameter, the tube length, the tube core diameter, and the sealing of the tube ends, a wide variety of drug therapeutic amounts, rates and dosing times can be achieved.

Claims

1. A pharmaceutical composition comprising:

a pharmaceutically suitable carrier and at least one drug delivery system consisting essentially of (1) a plurality of polymeric tubes having thin outer membrane sheaths and hollow cores, the length of each tube independently in the range of about 0.5 mm to about 5 cm, and (2) at least one solid, nonvaporizable drug compound contained within the cores, said system contained in the composition in an amount sufficient to deliver a therapeutic amount of the drug contained therein at a predetermined rate over a predetermined period of time.

2. The composition of claim 1 wherein the membrane outer sheath is impermeable and the tube ends are open.

3. The composition of claim 2 wherein the membrane outer sheath is permeable of semi-permeable.

4. The composition of claim 3 wherein 0 to 2 of the tube ends of each tube are sealed.

5. The composition of claim 1 wherein the core diameter is in the range of about 25%-90% of the outside diameter.

6. The composition of claim 1 wherein the drug compound concentration is in the range of about 1-90% by weight of the total weight of each tube and compound.

7. The composition of claim 5 wherein the concentration is in the range of about 5-75% by weight, and the length of each tube is independently in the range of less than 0.5 mm to about 6 mm, and whose aspect ratio is from about 1 to 30.

8. The composition of claim 5 wherein the membrane outer sheath of at least a portion of the tubes is permeable to water but not to the compound contained in the core, and these tubes have one end open and one end sealed.

9. The composition of claim 8 wherein the compound in the core is mixed with a pharmaceutically suitable salt or sugar.

10. The composition of claim 1 in the form of a capsule, tablet, or suppository.

11. The composition of claim 1 wherein the polymeric tube is formed from a polyolefin, a polyurethane, a copolymer of ethylene and vinyl acetate having at least 33% by weight vinyl acetate, a polyvinyl alcohol, or a blend of one of the aforesaid with a water-soluble polymer or salt.

12. The composition of claim 11 wherein the polymer is polypropylene having a melt index above 30 g/10 min and a solubility in hexadecylamine solvent above 20% w/w.

13. The composition system of claim 11 wherein the polymer is an ethylene-vinyl acetate copolymer having a melt index above 30 g/10 min and a solubility in a hydrocarbon solvent above 20% w/w.

14. The composition of claim 11 wherein the polymer is a segmented polyurethane/urea derived from polyether glycol soft segment containing no extra additives and soluble to greater than 30% w/w in dimethylacetamide or N-methylpyrrolidone.

15. The composition of claim 11 where the polymer is an ethylene-vinyl acetate copolymer blended with about 5 to 30% by weight of polyvinylpyrrolidone having a number average molecular weight of 15,000-40,000 or polyethylene glycol having a number average molecular weight of 400-20,000.

16. The composition of claim 14 wherein the polyurethane is a blend with about 5-50% by weight of polyvinylpyrrolidone having a number average molecular weight of 15,000-40,000 or polyethylene glycol having a number average molecular weight of 400-20,000.