Abstract
<span class="a"><span lang="EN-US">The requirements for the selection of excipients during the pharmaceutical development of semi-solid medicinal preparations for cutaneous application were generalized from a point of view of their impact on the quality, efficacy and safety of medicinal preparations. It was justified which excipients from the examined groups should be used for the pharmaceutical development of ointments, gels, and creams. The information about physico-chemical and technological properties of excipients and their compatibility was summarized.</span></span>
Highlights
The composition of a dosage form (DF) in addition to the active pharmaceutical ingredients (APhIs) includes excipients (Es), which is one of the pharmaceutical factors influencing the pharmaco-therapeutic effect of medicinal preparations (MPs)
The selection of a semi-solid dosage forms (SSDFs) composition and technological methods is performed on the stage of pharmaceutical development (PD), where grounds of quality, efficacy and safety of a MP are built in
The objects of research on PD are all components of a MP (AphI and Es), and DF, technological process and packaging materials, microbiological properties of the MP and compatibility of components [1,2,3]
Summary
The composition of a dosage form (DF) in addition to the active pharmaceutical ingredients (APhIs) includes excipients (Es), which is one of the pharmaceutical factors influencing the pharmaco-therapeutic effect of medicinal preparations (MPs). An important factor of the medicinap preparation (MP) effectiveness is compatibility between active pharmaceutical ingredient (AphI) and Es. Es possess appropriate physico-chemical properties and, depending on its nature, can enter into a more or less complex interaction with APhIs and the environment. In the manufacture, packaging, storage and distribution of semi-solid preparations for cutaneous application, suitable steps should be taken to ensure their microbiological quality according to the monograph of State Pharmacopoeia of Ukraine (SPU) «Microbiological quality of pharmaceutical preparations».
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