ФОРМУЛАЦИЈА И ЕВАЛУАЦИЈА НА ИБУПРОФЕН ПЕРОРАЛНА СУСПЕНЗИЈА 100 mg/5 ml
FORMULATION AND EVALUATION OF IBUPROFEN PERORAL SUSPENSION 100 mg/5 ml

Summary/Abstract: Ibuprofen is a widely used medicine from the group of non-steroidal anti-inflammatory drugs (NSAIDs) and its development. The development of Ibuprofen oral suspension was in accordance with the requirements prescribed in possesses analgesic, antipyretic and anti-inflammatory properties. Based on the market analysis, the properties of the active substance and the intention to cover a pediatric group of patients as a product for development, an oral suspension was chosen. Due to their thermodynamic instability, formulating a stable suspension is a complex process followed by many challenges during the ICH Q8 guideline for pharmaceutical development. In order to understand the problem of suspensions, as well as to enable easier facing of the challenges during its development, already in the early phase of the pre-formulation research, risk-based analyzes of changing variables and process parameters were made on the defined critical characteristics of the product. The realization of the experiments and all the tests required for the purpose of this paper were carried out in the laboratory premises of the pharmaceutical company GALAFARM DOO, Skopje, Republic of North Macedonia. The aim of this paper is the development of a liquid dosage form – a suspension for oral administration, which will ensure the appropriate release of the prescribed dose of the active substance in the human body. At the same time, it will meet the prescribed requirements according to the appearance, viscosity, color, smell and taste to be acceptable to the target group of patients - children from 3 months to 12 years, as well as chemical and physical characteristics and to ensure the stability of the active substance. For this purpose, four formulations of Ibuprofen oral suspension 100 mg /5 ml were made where the main variables were the suspending agents/viscosity adjustment. The anionic surfactant polysorbate 80 was also taken as a variable, which is of crucial importance, primarily because it is a class II active substance according to the biopharmaceutical classification of drugs. The samples were evaluated according to the appropriate tests prescribed in the current editions of the European Pharmacopoeia [PhEur.], the British Pharmacopoeia [BP] and the United States Pharmacopoeia [USP], and some of the parameters were also tested according to the company's internal methods. From the tested formulations, only with formulation 2, 3 and 4 were obtained results that satisfy the requirements prescribed in the quality specification for Ibuprofen oral suspension 100 mg/5 ml, but the most acceptable organoleptic characteristics, appearance, consistency and taste were achieved by formulation 3, which was chosen for further and additional investigations.

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