Pharmaceutical development of tablets based on cryolyophilized porcine skin

Abstract

Among natural sources of animal origin, the most similar to human in composition is porcine skin. Crushed cryolyophilized xenoderm of porcine skin from 1st layer is used for preparation a dietary supplement Xenoderm in the form of powder, capsules and tablets. Also, an additional natural active pharmaceutical ingredient is 2nd layer from cryolyophilized xenoderm of porcine skin, which was not used before. In this study, composition and technology of combined tablets based on the powders of the 1st and 2nd layers from the cryolyophilized xenoderm of porcine skin were develop and characterized. It was evaluated pharmaco-technological properties of the tableting blend such as bulk density, tapped density, flowability and angle of repose. The tablets were prepared by direct compression method. They were studied for appearance, uniformity of dosage units, hardness, friability and disintegration. The effect of fillers, disintegrants, and glidants on 9 pharmaco-technological properties of the tableting blend and tablets was investigated using dispersion analysis. By desirability function the advantages of Neusilin® US2, calcium dihydrogen phosphate anhydrous and sorbitol, croscarmellose sodium and polyplasdone XL-10 are shown. The quantities of excipients were investigated using method of random balance. The interaction between quantities of excipients and the quality of tableting blend and tablets was proved using method of regression analysis. Optimal combination of croscarmellose sodium, Neusilin® US2, microcrystalline cellulose 102 and magnesium stearate is justified. New combined tablets under the conventional name Combiderm are obtained by direct compression method. Optimal tablet pressing parameters are selected in the range from 290 ​MPa to 435 ​MPa. We successfully prepared the tablets with a good consumer appearance and conformity pharmacopoeial requirements. The proposed methodology could be an algorithm for the pharmaceutical development of other combined tablets using statistical methods.