FIELD: injectable sustained release formulation.
SUBSTANCE: invention relates to an injectable sustained release formulation. The method for producing a filler includes the following steps: (a) PLLA is mixed with CMC and mannitol, freeze-dried, crushed to a certain size and sterilized using gamma radiation; (b) HA is mixed with BDDE crosslinker, gelled, washed with phosphate buffer, crosslinked HA with identical particles is collected and passed through a sieve; (c) homogenizing the base core material containing the bioactive material, the mixture from step (a), the biodegradable polymer and the organic solvent to form an emulsion; (d) adding distilled water to cross-linked HA to form a wall material; (e) mixing the emulsion with the wall material; (f) performing spray drying; where freeze drying in step (a) includes: performing the main freeze drying at a temperature of -60 to -100°C for 12-24 hours; performing additional drying at a temperature of 15-25°C for 5-10 days, the size of the crushed particles is in the range of 30-100 microns.
EFFECT: invention provides improved initial volume and suspension uniformity.
5 cl, 3 ex
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