Lyophilization of protein and peptide anticancer drugs is a promising method to create a stable and effective parenteral dosage forms. This article reviews the main problems encountered during lyophilization of protein and peptide drugs, and describes the best practices for solving these problems. The ways of optimization and improvement of the freeze-drying are given. Temperatures to improve the properties and prevent the destruction of the cake lyophilizatiе are suggested.
Technologies for obtaining dosage formulations (DF) for personalized therapy are currently being developed in the field of inkjet (2D) and 3D printing, which allows for the creation of DF using various methods, depending on the properties of pharmaceutical substances and the desired therapeutic effect. By combining these types of printing with smart polymers and special technological approaches, so-called 4D printed dosage formulations are obtained. This article discusses the main technological aspects and used excipients of a polymeric nature for obtaining 2D, 3D, 4D printed dosage formulations. Based on the literature data, the most widely used polymers, their properties, and application features are determined, and the technological characteristics of inkjet and additive 3D printing are shown. Conclusions are drawn about the key areas of development and the difficulties that arise in the search and implementation in the production of new materials and technologies for obtaining those dosage formulations.
This work aimed to develop and characterize a water-soluble, high-release active pharmaceutical ingredient (API) composite based on the practically water-insoluble API N-butyl-N-methyl-1-phenylpyrrolo[1,2-a]pyrazine-3-carboxamide (GML-3), a substance with antidepressant and anxiolytic action. This allows to ensure the bioavailability of the medicinal product of combined action. Composites obtained by the method of creating amorphous solid dispersions, where polyvinylpyrrolidone (PVP) or Soluplus® was used as a polymer, were studied for crystallinity, stability and the release of API from the composite into purified water. The resulting differential scanning calorimetry (DSC), powder X-ray diffractometry (PXRD), and dissolution test data indicate that the resulting composites are amorphous at 1:15 API: polymer ratios for PVP and 1:5 for Soluplus®, which ensures the solubility of GML-3 in purified water and maintaining the supercritical state in solution.
This review presents technological approaches to 4-D printing, which are modifications of additive technologies. Showing the distinctive features of this technology from the three-dimensional printing. The use of four-dimensional printing in pharmaceutical technology and advantages over traditional methods of creating dosage forms are described. Demonstrated classification of adaptive materials, the principles of their application and features of printing equipment. Examples of adaptive materials are presented, including smart polymers and stimuli sensitive hydrogels. The advantages of this type of production, its development prospects and technological features of the production of microcapsules, hydrogels and mucoadhesive films of smart polymers by additive printing technology are given.
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