Sustained release delivery system

• US 6,335,035 B1
• Filed: 02/28/2000
• Issued: 01/01/2002
• Est. Priority Date: 09/29/1995
• Status: Expired due to Term

• Current Assignee: Glycobiosciences Incorporated
• Original Assignee: L.A.M. Pharmaceutical, Corp.
• Inventors: Nath, Gary M., Drizen, Alan, Rothbart, Peter
• Primary Examiner(s): Dudash, Diana
• Assistant Examiner(s): Haghighatian, Mina
• Application Number:
  US09/514,163
• Time in Patent Office: 673 Days
• Field of Search: 424/484, 424/486, 424/488, 424/78.08, 424/485, 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 sustained release delivery system, which comprises:

an active therapeutic drug dispersed with a polymer matrix which is solubilized or suspended in a liquid medium;

wherein the polymer matrix consists of hyaluronic acid of salts thereof blended with a nonionic polymer selected from the group consisting of hydroxyethylcellulose, hydroxypropylcellulose and mixture thereof;

and wherein the molar ratio of the hyaluronic acid or salts thereof to the nonionic polymers 1;

0.5 to 2.0.

2. The sustained release delivery systems of claim 1, wherein the hyaluronic acid salt is the sodium salt and has a sulphated ash content below about 15%, a protein content below about 5%, and is 95-100% free from contamination of related mucopolysaccharides.

3. The sustained release delivery system of claim 1, wherein the polymer matrix is an injectable solution.

4. The sustained release delivery system of claim 1, wherein the polymer matrix is a topical gel.

5. The sustained release delivery system of claim 1, wherein the nonionic polymer is hydroxyethyl cellulose.

6. A sustained release delivery system, which comprises:

a polymer matrix suspended of solubilized in a liquid medium, wherein the polymer matrix contains mucopolysaccharides and derivatives thereof, blended with a nonionic polymer selected from the group consisting of hydroxyethylcellulose, hydroxypropylcellulose and mixtures thereof, and wherein the molar ratio of the negative charged polymer to the nonionic polymer is 1;

0.5 to 2.

7. The sustained release release delivery systems of claim 6, wherein the muscopolysaccharide is hyaluronate acid of salts thereof and is selected from the group consisting of sodium, calcium, potassium or magnesium salt.

8. The sustained release delivery system of claim 6, wherein the nonionic polymer is selected from the group consisting of hydroxyethyl cellulose, hydroxypropyl cellulose and mixtures thereof.

9. The sustained release delivery system of claim 6, wherein the molar ratio of the polymers is 1:

0.8 to 1.5.

10. The sustained release delivery system of claim 6, where the hyaluronic acid or salts thereof is present in amounts of about 0.1% to about 2.0% by weight.

11. The sustained release delivery system of claim 6, wherein the nonionic polymers are present in amounts of about 0.1% to about 1.0% by weight.