Method for the determination of residual formaldehyde in an inactivated Zika vaccine formulated with aluminum hydroxide gel.

A simple method for the determination of low levels of residual formaldehyde in an inactivated Zika vaccine formulated with aluminum hydroxide gel was developed for the assessment of drug product quality. Formaldehyde was reacted with 2,4-dinitrophenylhydrazine (DNPH) and the derivatized product was detected by HPLC with an UV detector at 360 nm. The derivatization reaction could be carried out in a 2-mL HPLC vial and the sample was analyzed directly.

A new animal model for evaluation of long-term growth rate over one month by rhGH/PLGA microcapsule formulations.

A new animal model to evaluate the long-term growth rate produced by a sustained-release formulation of recombinant human growth hormone (rhGH) over one month was developed and the usefulness of our microcapsule formulations was demonstrated in this model. Long-term pharmacological effects by subcutaneous injection of microcapsules for sustained release of rhGH were evaluated in hypophysectomized (Hpx) rats treated with immunosuppressive agent along with hormone supplement. Copoly(DL-lactic/glycolic)acid (PLGA) microcapsules for sustained release of rhGH, a two-week sustained-release formulation (rhGH-SR-2W) and a one-month sustained-release formulation (rhGH-SR-1M), were prepared by a solid-in-oil-in-water emulsion solvent evaporation technique.

Sustained release of human growth hormone from microcapsules prepared by a solvent evaporation technique.

Biodegradable microcapsules for sustained release of recombinant human growth hormone (rhGH) were prepared by a solid-in-oil-in-water (S/O/W) emulsion solvent evaporation technique using lyophilized protein microparticles. The minimum mean particle size of rhGH in S/O dispersions was 2.8-3.

Preparation of a copoly (dl-lactic/glycolic acid)-zinc oxide complex and its utilization to microcapsules containing recombinant human growth hormone.

A procedure to prepare a complex of copoly (dl-lactic/glycolic acid) and zinc oxide (PLGA-zinc oxide complex) was developed. Out of sparingly water-soluble zinc compounds, zinc oxide was most remarkably soluble in a PLGA/dichloromethane solution and the dissolution rates became faster as the water contents in the PLGA/dichloromethane solutions increased. Since the solubility of zinc oxide was saturated at approximately 0.