[Selected adjuvants as carriers of a dry extract of common ivy (Hedera helix L.)]. / Wybrane substancje pomocnicze jako nosniki suchego ekstraktu z lisci bluszczu pospolitego (Hedera helix L.).

The usefulness was tested of selected adjuvants: Vivapur 112, Carmellose calcium, Calcium carbonate CA 740, Calcium carbonate CA 800, Hypromellose as carriers of a dry extract of common ivy (Hedera helix L.) leaves in the process of direct tableting. The quality of the produced tablets was determined by examining their appearance, diameter, thickness, mass resistance to abrasion, crushing and disintegration time. Furthermore, the rate of release of biologically active components from the produced drug form to acceptor fluid was tested in accordance with the requirements of Polish Pharmacopoeia VII (PPVII). An attempt was made to estimate the effect of the used adjuvants on the course of this process. The applied adjuvants and acceptor fluid osmolarity decide significantly about the pharmaceutical availability of the therapeutic agents contained in the extract. The obtained model tablets are characterized by controlled release of biologically active substances, in majority of batches they fulfil the requirements as regards physicochemical properties. The formulation composition of the first batch (Extr. Hederae helices e fol.spir. sicc., Vivapur 112, Carmellose calcium, Sodium Stearyl Fumarate) appeared to be the most effective. The worked out method is optimal and provides technological reproducibility and high durability of the drug form.

Application of silicified microcrystalline cellulose (Prosolv) as a polymer carrier of Epilobium parviflorum Schreb. extract in oral solid drug form.

Direct tableting is simpler and more cost-effective from the point of view of good manufacturing practice (GMP) than wet granulation or dry compacting. Thus, pharmaceutical industry more and more frequently uses this particular process. Only few therapeutic substances form under compression tablets meeting current requirements. Very often additional adjuvants must be used. These substances have the ability of increasing plastic deformation and tablet mass liquidity. Microcrystalline cellulose belongs to the best adjuvant substances of the type. It has binding, disintegrating and improving liquidity properties. This study aims at investigating the usefulness of selected high-molecular substances with particular consideration of silici-fled microcrystalline cellulose (Prosolv) and croscarmellose sodium (Vivasol) as a carrier of E. parviflorum Schreb. extract in oral solid drug form in the process of direct tab-leting. The manufactured tablets were subjected to morphological tests and pharmaceutical availability tests of biologically active substances from a tablet to the acceptor fluid. The investigations were based on general and detailed principles of Polish Pharmacopoeia VI. The obtained results allow to state that the applied high-molecular adjuvant substances proved to be useful in adequate proportions in the production of tablets from dry extract from Epilobium parviflo-rum Schreb. Generally, a significant shortening of the tablets disintegration time was obtained as compared to earlier produced tablets with the method of initial granulation. The tablets formed from E. parviflorum Schreb. extract with silicified microcrystalline cellulose (Prosolv SMCC 50) and croscarmellose sodium can be included into preparations of short dissolution time of the therapeutic substance.

The effect of chitosan on the stability and morphological parameters of tablets with Epilobium parviflorum Schreb. extract.

The study is a continuation of research on manufacturing oral solid drug form containing extract from Epilobium parviflorum Schreb. This study aims at investigating the usefulness of selected high-molecular substances with particular consideration of chitosan (Ch), silicified microcrystalline cellulose (Prosolv) and croscarmellose sodium (Vivasol) as a carrier of E. parviflorum Schreb. extract in oral solid drug form in the process of direct tableting. In one series the alternative technological process (with initial granulation) was applied. The polymer carriers of extract were selected so as to obtain shorter disintegration time in relation to the earlier published studies and stability after longer time of storage. The effect of chitosan was estimated on selected morphological parameters of practical relevance during storage. The obtained results allow to state that the applied high-molecular adjuvant substances proved to be useful in adequate proportions in the production of tablets from dry extract from Epilobium parviflorum Schreb. through direct pressing of the tablet mass. The tablet properties in all series were in accordance with obligatory standards also after longer time of storage (12-month). The tablets formed from E. parviflorum Schreb. extract with chitosan can be included into preparations of sustained release time of the biologically active substances.