PubMed · 11987748
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Byeong S Chang, Susan Hershenson. 2002. Practical approaches to protein formulation development.. https://doi.org/10.1007/978-1-4615-0557-0_1
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The slurry equilibration method used to determine the relative physical stability of polymorphs is extended to a crystal system of an anhydrate and hydrate. The method involves preparation of organic/aqueous slurries of known water activity containing mixtures of the anhydrate and hydrate forms. The slurries equilibrate to the lowest free energy form, from which the relative physical stability is determined as a function of relative humidity. The method is particularly valuable when one or more of the crystal forms is kinetically stable, since solvent-mediated transformation accelerates the conversion process. Results are provided for GW2016 anhydrate and monohydrate crystal forms, for which it was determined that interconversion occurs between 7 and 15% relative humidity.
The preparation of colloidal particles of different morphologies, including spheres, of two drugs, loratadine and danazol, is described. In principle these particles were obtained by precipitation when nonsolvents (water or aqueous surfactant solutions) were added to ethanol solutions of the drug. In addition, procedures were developed that made it possible to use the drug particles thus obtained as cores to be then coated with either silica or aluminum (hydrous) oxide layers. The presence of these inorganic shells was confirmed by electron microscopy, energy dispersive spectroscopy, and electrophoresis.
Glycerol monooleate (GMO) matrix was found to be a gastro-retentive carrier system suitable for both polar and as well as non-polar drugs. Chlorpheniramine maleate (CPM) and diazepam (DZP) were used as model drugs. Effect of PEG 4000, PEG 10000, and stearic acid on floatability and release profile was studied. Water uptake increased with increase in the loading of polar drug (CPM) and decreased with non-polar drug (DZP). Similar effect was found to occur in case of drug release. PEGs increased the release up to certain concentration and decreased thereafter. Drug release decreased linearly with concentration of stearic acid. The type and extent of mesophases formed were significantly affected by the nature of drug, excipients and their concentration. Thus the selection of suitable excipients depending on polarity of drug, could help to modulate the floatability and release profile from GMO matrices.