Radiation sterilization of hypercompressed polymer dosage forms

1. A sterile pharmaceutical dosage form which comprises an ester capped lactide polymer, ester capped glycolide polymer or an ester capped lactide-glycolide copolymer that is hypercompressed with an active pharmaceutical ingredient wherein said sterile pharmaceutical dosage form has been sterilized with an electron beam.

2. A sterile pharmaceutical dosage form as defined in claim 1 where the active pharmaceutical ingredient is selected from the group consisting of steroids, non-steroidal anti-inflammatory drugs, antihistamines, antibiotics, mydriatics, beta-adrenergic antagonists anesthetics,alpha-2-beta adrenergic agonists, mast cell stabilizers, prostaglandin analogues, sympathomimetics, parasympathomimetics, antiproliferative agents, agents to reduce ocular angiogenesis and neovascularization, vasoconstrictors, anti-neoplastic agents, a polynucleotide, or a recombinant protein analog an angiogenic inhibitors and combinations thereof.

3. A sterile pharmaceutical dosage form as defined in claim 2 where the therapeutic agent is a steroid.

4. A sterile pharmaceutical dosage form as defined in claim 1 where the polymer is selected from the group consisting of ester capped poly(dl-lactide), ester capped polyglycolide,ester capped poly(glycolide-co-lactide), and ester capped poly(glycolide-co-dl-lactide), or a mixture of any of the foregoing.

5. A sterile pharmaceutical dosage form as defined in claim 4 where the dosage form has been compressed by the application of 50K psi to 350K psi.

6. A sterile pharmaceutical dosage form as defined in claim 5 where the dosage form has been compressed by the application of 100 Kpsi to 300 Kpsi.

7. A sterile pharmaceutical dosage form as defined in claim 5 where the dosage form has been compressed by the application of 200 Kpsi to 300 Kpsi.

8. A method of preparing a sterile hypercompressed pharmaceutical dosage form according to claim 1 where the active pharmaceutical ingredient is selected from the group consisting of peptides and proteins.

9. A method of preparing a sterile hypercompressed pharmaceutical dosage form of an ester capped lactide polymer, ester capped glycolide polymer or an ester capped lactide-glycolide copolymer which comprises:

(a) combining an active pharmaceutical ingredient with an ester capped lactide polymer, an ester capped glycolide polymer or an ester capped lactide-glycolide copolymer to form a powdered product;

(b) hypercompressing the powdered product of step (a) to form a hypercompresed dosage form; and

(c) exposing the hypercompressed dosage form of step (b) to a sterilizing amount of an E-beam radiation source to form a sterilized product.

10. A method of preparing a sterile hypercompressed pharmaceutical dosage form according to claim 9 where the active pharmaceutical ingredient is selected from the group consisting of steroids, non-steroidal anti-inflammatory drugs, antihistamines, antibiotics, mydriatics, beta-adrenergic antagonists anesthetics, alpha-2-beta adrenergic agonists, mast cell stabilizers, prostaglandin analogues, sympathomimetics, parasympathomimetics, antiproliferative agents, agents to reduce ocular angiogenesis and neovascularization, vasoconstrictors, anti-neoplastic agents, a polynucleotide, or a recombinant protein analog an angiogenic inhibitors and combinations thereof.

11. A method of preparing a sterile hypercompressed pharmaceutical dosage form according to claim 9 where the dosage form has been compressed by the application of 50K psi to 350K psi.

12. A method of preparing a sterile hypercompressed pharmaceutical dosage form according to claim 9 where the dosage form has been compressed by the application of 100 Kpsi to 300 Kpsi.

13. A method of preparing a sterile hypercompressed pharmaceutical dosage form according to claim 9 where the dosage form has been compressed by the application of 200 Kpsi to 300 Kpsi.