EXTEMPORAL CHEWABLE PASTILLES: FROM THE CONCEPT OF THE DOSAGE FORM TO QUALITY CONTROL

113 Volume 5, Issue 10: Special Issue (EJAR) ISSN: 2181-2020 MPHAPP THE 6TH INTERNATIONAL SCIENTIFIC AND PRACTICAL CONFERENCE “MODERN PHARMACEUTICS: ACTUAL PROBLEMS AND PROSPECTS” TASHKENT, OCTOBER 17, 2025 in-academy.uz EXTEMPORAL CHEWABLE PASTILLES: FROM THE CONCEPT OF THE DOSAGE FORM TO QUALITY CONTROL Inkin A.D.1 Krishtanova N. A.2 Saint-Petersburg State University of Chemistry and Pharmacy, Saint-Petersburg, Russian Federation e-mail: [email protected] https://doi.org/10.5281/zenodo.17324225 Relevance. Chewable pastilles combine taste masking, ease of use and the ability to select individual doses, which is especially valuable in pediatrics, geriatrics and for patients with dysphagia. For pharmacies, the form is attractive for its technological simplicity, availability of bases (for example, gelatin) and the possibility of rapid production of small batches. However, methodological gaps remain: terminological uncertainty and differentiation with related forms, lack of regulated procedures for quality control and stability in the conditions of extemporal production. Comparison with the requirements of the Pharmacopoeia and development of simplified, reproducible algorithms and rapid control methods are critical for safe implementation in pharmacy practice. Objective: to study chewable pastilles as a dosage form, to justify their suitability for extemporal manufacture in a pharmacy and to demonstrate the simplicity of the technological process and quality control. Tasks: 1. Clarify the definition of "chewable pastilles", indicate their place in the nomenclature of dosage forms and distinguish them from chewable tablets, lozenges and pastilles. 2. Justify the suitability of the mold for extemporal production in pharmacies. 3. Suggest rapid quality control methods based on the requirements of the Pharmacopoeia. Materials and methods: The study was based on pharmacopoeial articles of the State Pharmacopoeia of the Russian Federation and scientific articles on quality control of chewable pastilles. The analysis uses the following methods: content analysis, descriptive and comparative analysis. Results: Chewable pastilles are a dosage form in which the active substance is distributed in an elastic‑plastic, non-flowing base. Unlike pastilles and lozenges, this form is designed for chewing and is mainly focused on achieving a systemic effect. Organoleptic deficiencies of medicines are effectively leveled by the use of flavorings and sweeteners, which increases adherence to treatment. The technological process is relatively simple and involves melting the gelatin mass with subsequent dosing of the melt into silicone molds. As an express method of quantitative analysis, titrimetry is suitable after sample preparation, which consists in dissolving the lozenge in a boiling water bath with subsequent cooling. Conclusions: chewable pastilles are a dosage form with an elastic-plastic, non-flowing base, intended for chewing and mainly systemic action. The mold is technologically available for extemporal production in pharmacies. Simple technological schemes (gelatin mass melt - dosage into molds) and express control (titrimetry after dissolution in a water bath) are proposed. For safe implementation, chewable pastilles should be separated as an independent dosage form and accelerated methods should be developed according to the requirements of the Pharmacopoeia with their subsequent validation.