CURRENT STATUS AND PROSPECTS FOR THE DEVELOPMENT OF PEDIATRIC DOSAGE FORMS BY THE EXAMPLE OF COMBINED MELOXICAM AND VITAMIN B12 TABLETS.

Abstract

Relevance: In the Republic of Kazakhstan, the pharmaceutical industry is undergoing rapid development. However, there is a significant deficit of specialized dosage forms for children. The majority of pharmaceuticals employed in paediatric practice have not been subjected to clinical trials in children, resulting in irrational prescribing and an elevated risk of adverse effects. The development of paediatric dosage forms for the treatment of socially significant diseases, such as juvenile rheumatoid arthritis (JRA), is of particular urgency. This article discusses the prospect of developing combined meloxicam and vitamin B12 tablets for children, which may improve the efficacy and safety of therapy.

Materials and methods: The study was carried out on the basis of South Kazakhstan Medical Academy and research testing center of JSC "Khimpharm". Physicochemical and technological properties of meloxicam and cyanocobalamin were studied and five model samples of core tablets were developed. Direct pressing methods, as well as dissolution and active substance release tests were used to assess the quality of tablets. The production technology included the stages of mixing, pressing and film coating.

Results: According to the Register of medicines of the Republic of Kazakhstan and the Kazakhstan National Formulary, only 0.3% of the total number of medicines are intended for children. 1.7% of medicines for children are included in the list of medicines for free and (or) preferential outpatient supply to citizens of Kazakhstan. 61 preparations of meloxicam are registered on the pharmaceutical market of Kazakhstan, but there are no preparations for children among them. Combination therapy has advantages over monotherapy, the simultaneous use of several active pharmaceutical ingredients reduces the duration of treatment and reduces the need for additional drugs. The results of determining the physicochemical and technological properties of meloxicam, cyanocobalamin and excipients showed that they meet the requirements of regulatory documents. Taking this into account, the method of direct pressing was chosen as a rational way of tableting meloxicam with cyanocobalamin. The data on quality indicators (by mass, height, diameter, hardness) and dissolution kinetics study showed that the composition no.4 of model samples of meloxicam core tablets is optimal. The technology of production of combined meloxicam tablets for children with an average weight of 62.0 mg ±10% (from 55.8 mg to 68.2 mg) coated was developed, and the pilot technology was tested on 2448.00 g of tablet mass.

Conclusion: The development of combined meloxicam and vitamin B12 tablets for children represents a promising direction in the field of pharmaceutics. This dosage form has the potential to enhance the effectiveness of therapy for juvenile rheumatoid arthritis and other inflammatory diseases in children, whilst concomitantly reducing the likelihood of adverse effects. The results of the study indicate the necessity for additional clinical trials to be conducted, including bioavailability and stability tests, on the developed paediatric dosage form.