Methodological approaches to the development of the capsules «Phytohelmin» composition
The existing range of medicines is represented by a variety of dosage forms. Among them a significant proportion takes oral solid dosage forms, in particular capsules. The introduction of active pharmaceutical ingredients in the capsule composition does not require the addition of flavouring agents and requires a significantly lower amount of excipients compared to the formation of tablet dosage forms.
In the development of dosage forms based on extracts of medicinal plants, the rational choice of the dosage form is important. The use of capsules allows making a composition of several extracts, providing the proper consumer characteristics of the finished product.
The aim of the workis to study methodological approaches to the development of the drug «Phytohelmin», proposed for use in the 3rd phase of the treatment of helminthiasis of the digestive system.
As the objects of research scientific works of domestic and foreign authors, databases and own findingswere selected. When conducting the own research, we used methods of bibliosemantic analysis, systematization and generalization of data.
Capsules are characterized as a dosage form: the definition, classification, features, advantages and disadvantages are presented. When developing a medicine for the treatment of helminthiases of the digestive system in phase III (eliminating the consequences of the disease and restoring the functions of the gastrointestinal tract), we selected the solid capsule dosage form. We present a decision tree for 6 stages of choosing the medicinal plant material to justify the capsule composition under the conditional name «Phytohelmin».
7 Degrees of the general algorithm for pharmaceutical development of capsules are described and solutions for each stage directly for the capsules of the proposed composition are given.
Based on the results obtained, the main methodological approaches to the development of drugs in the form of capsules are formulated, in particular, capsule characteristics and classification are given, and the advantages and disadvantages of this dosage form are analyzed. The tree of decisions on the choice of medicinal plant materials in the development of medicines and the final composition of the capsules «Phytohelmin», obtained on the basis of its application, is given. The general algorithm for the pharmaceutical development of capsules and the corresponding solutions for the development of «Phytohelmin» capsules based on it in accordance with the requirements of Guide 42-3.1: 2004 «Quality Guide. Medications. Pharmaceutical Development» is described.
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