Sustained release delivery system

• US 6,063,405 A
• Filed: 01/08/1998
• Issued: 05/16/2000
• Est. Priority Date: 09/29/1995
• Status: Expired due to Term

• Current Assignee: Glycobiosciences Incorporated
• Original Assignee: L.A.M. Pharmaceuticals, LLC
• Inventors: Nath, Gary M., Drizen, Alan, Rothbart, Peter
• Primary Examiner(s): Harrison, Robert H.
• Application Number:
  US09/049,653
• Time in Patent Office: 859 Days
• Field of Search: 424/484, 424/78.08, 424/486, 424/488, 514/54, 514/568, 514/777, 514/781, 514/825, 514/886, 514/887, 514/944, 536/53, 548/500, 549/554, 560/47, 562/426, 562/492, 564/141, 564/144
• US Class Current: 424/488
• CPC Class Codes: A61K 31/196 the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
• CPC Class Codes: A61K 47/36 Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
• CPC Class Codes: A61K 47/38 Cellulose; Derivatives thereof
• CPC Class Codes: A61K 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/0034 Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
• CPC Class Codes: A61K 9/06 Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels composition of ointments, creams or gels A61K47/00
• CPC Class Codes: A61K 9/08 Solutions composition of solutions A61K47/00

Abstract

Sustained release compositions comprising a drug dispersed within a polymer matrix, methods of producing the same and treatments with the complex.

Claims

1. A method for making a sustained release delivery system which comprises:

blending an aqueous solution of a negatively charged polymer selected from the group consisting of hyaluronic acid, hyaluronic acid salt and mixtures thereof with an aqueous solution of a nonionic polymer selected from the group consisting of hydroxyethylcellulose, hydroxypropylcellulose and mixtures thereof to form a stable polymer matrix;

sterilizing the stable polymer matrix; and

wherein said stable polymer matrix continuously releases an active therapeutic drug for at least 24 hours when administered to an animal;

wherein the molar ratio of the negatively charged polymer to the nonionic polymer 1;

0.5 to 2.

2. The method of claim 1, wherein the hyaluronic acid salt is sodium hyaluronate having a sulphated ash content below 15% and a protein content below 5%.

3. The method of claim 1, wherein the nonionic polymer is hydroxyethyl cellulose.

4. The method of claim 1, which further comprises suspending or solubilizing an active drug within the stable polymer matrix.

5. The method of claim 1, wherein the negatively charged polymer is the hyaluronate salt of sodium, calcium, potassium or magnesium.

6. The method of claim 1, wherein the nonionic polymer is hydroxypropyl cellulose.

7. The method of claim 1, wherein the molar ratio of the negatively charged polymer to the nonionic polymer is 1:

0.8 to 1.5.

8. The method of claim 1, wherein the negatively charged polymer is present in amounts of 0.1% to 2.0% by weight of the stable polymer matrix.

9. The method of claim 1, wherein the nonionic polymer is present in amounts of 0.1% to 1.0% by weight of the stable polymer matrix.

10. The method of claim 1, wherein the negatively charged polymer solution is added to the nonionic polymer solution.

11. The method of claim 1, wherein the nonionic polymer solution is added to the negatively charged polymer solution.