Implantable gel compositions and method of mfg.
A composition and gel technology, applied in the preparation of the composition, a carrier such as a composition of a gel and a beneficial agent, at least occupying a sparse field, can solve problems such as difficulty in administration of active agents, and achieve the effect of reducing burst release
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Embodiment 1
[0119] A glass vessel was tared on a Mettler PJ3000 top-loading balance. Weigh poly(D,L-lactide-co-glycolide) 50:50 RESOMER® RG502 (PLGA-502) and place it in a glass container. Tare a glass container containing PLGA-502 and add the corresponding solvent. See Table 1 for the weight percentages of various polymers / solvents used in combination. The polymer / solvent mixture was stirred by hand with a stainless steel square-tipped spatula to obtain a viscous amber paste containing white polymer particles. The vessel containing the polymer / solvent mixture was sealed and placed in an incubator at a constant temperature of 37-39°C. When the polymer / solvent mixture became a clear amber homogeneous gel, it was removed from the incubator. The incubation time interval can be 1-4 days, depending on the type of solvent and polymer and their ratio. Other depot gel carriers were prepared using the following polymers and solvents or mixtures: the polymer was poly(D, L-lactide-co-glycolide) ...
Embodiment 2
[0120] Prepare human growth hormone (hGH) particles (optionally containing zinc acetate) as follows:
[0121] Spray Dryer Parameters
[0122] frozen
[0123] The resulting hGH particles have a particle size of 2-100 microns. Example 3
Embodiment 3
[0125] The benefit agent / stearic acid-containing compressed microparticles prepared above were added at 10-20% by weight to the gel carrier and mixed by hand until the dry powder was fully wetted. The creamy yellowish granule / gel mixture was then thoroughly mixed using a Caframo mechanical mixer with a square-tipped metal spatula using conventional mixing methods. The resulting homogeneous gel formulation was transferred to a 3, 10 or 30 cc disposable syringe for storage or dispensing.
[0126] A certain amount of gel for implantation was prepared according to the above method, and the in vitro release test of the beneficial agent was performed as a function of time, and the concentration of the beneficial agent in rat plasma was measured over time to study its release in vivo.
[0127] Such as figure 2 As shown, lysozyme, which does not form a compression mixture with stearic acid or palmitic acid, is released from the gel carrier more rapidly and at a higher rate when...
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