Slow release pharmaceutical preparation and method of...

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Implant or insert

Reexamination Certificate

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Details

C424S423000, C424S426000, C424S464000, C424S468000, C424S489000

Reexamination Certificate

active

07914804

ABSTRACT:
A pharmaceutical preparation adopted for sustained release of an active agent(s) over an extended period of time at a therapeutic rate without an initial burst release of the agent(s) upon administration, wherein the preparation comprises: (i) an outer portion prepared from one or more layers of a biodegradable polymer, which is selected to release an active agent over an extended period of time when positioned in situ in a patient, and (ii) an inner portion comprising a plurality of micro-capsules formed from at least a biodegradable polymer, said micro capsules containing at least an active agent, wherein the micro-capsules are compressed into the form of a tablet under suitable pressure to suppress the rate of release of the active agent from the micro-capsules. The present specification also relates to a method for inserting one or more implants(s) into a tissue of a mammal comprising the following steps: a) making a small incision into the tissue with a needle and a first sheath; b) withdrawing the needle from the first sheath but leaving the first sheath in the tissue; c) dilating the opening of the incision by inserting a dilator and second sheath of larger diameter through the body of the first sheath; d) withdrawing the dilator from the second sheath, but leaving the second sheath in the tissue; e) disturbing the implant(s) from a sheath filled with implant(s) by inserting said sheath into the final sheath inserted into the tissue and pushing a dilator into the sheath thereby releasing said implant(s) into the tissue.

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I. Soriano and C. Evora, “Formulation of calcium phosphates/poly (d,l-lactide) blends containing gentamicin for bone implantation,” Journal of Controlled Release, Elsevier Science Publishers, B.V. (Amsterdam, The Netherlands), vol. 68 ( No. 1), p. 121-134, (Jul. 17, 2000).
Schwope, A.D., et al., “Lactic/glycolic acid polymers as narcotic antagonist delivery systems,” Life Sciences, vol. 17 ( No. 12), p. 1877-1885, (Nov. 17, 1975).
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Reuning, R.H. et al., “Pharmacokinetic Quantitation of Naltrexone Release From Several Sustained-Relsease Delivery Systems”, NIDA Research Monograph, vol. 28, 1981, pp. 172-184.

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