Study of the technological properties of excipients in the development of the composition of orally dispersible tablets

Introduction. The article presents the results of studying the technological properties of individual excipients widely used in the compositions of existing orally dispersed tablets (ODT) for subsequent planning a multifactorial experiment. Samples of excipients were analyzed according to such pharmacopoeial indicators as description, flowability, bulk density, compressibility, fractional composition, solubility in water.Aim. The aim of the work is to create a list and study the technological properties of candidate substances for the role of auxiliary substances in the composition being developed by the ODT.Materials and methods. The technological properties of excipient samples were studied according to the methods of the State Pharmacopoeia of the XIV edition using the flowability tester GTL (ERWEKA, Germany), the bulk density tester SVM 221 (ERWEKA, Germany), the tablet press PGR-10 (LabTools, Russia) and the tablet hardness tester TBH 125 TDP (ERWEKA, Germany).Results and discussion. As a result of the study, experimental data on the technological properties of excipient samples were collected, and the selected samples were compared according to pharmaceutical and technological indicators.Conclusion. In the course of the study, a list of auxiliary substances for the development of the composition of ODT was formed and studies of their technological properties were carried out. The obtained experimental data will allow to develop an optimal matrix of a multifactorial experiment for the development of the composition of ODT and justify the choice of excipients.

Blend Segregation in Tablets Manufacturing and Its Effect on Drug Content Uniformity—A Review

Content uniformity (CU) of the active pharmaceutical ingredient is a critical quality attribute of tablets as a dosage form, ensuring reproducible drug potency. Failure to meet the accepted uniformity in the final product may be caused either by suboptimal mixing and insufficient initial blend homogeneity, or may result from further particle segregation during storage, transfer or the compression process itself. This review presents the most relevant powder segregation mechanisms in tablet manufacturing and summarizes the currently available, up-to-date research on segregation and uniformity loss at the various stages of production process—the blend transfer from the bulk container to the tablet press, filling and discharge from the feeding hopper, as well as die filling. Formulation and processing factors affecting the occurrence of segregation and tablets’ CU are reviewed and recommendations for minimizing the risk of content uniformity failure in tablets are considered herein, including the perspective of continuous manufacturing.

Natural Polymer Chitosan as Super Disintegrant in Fast Orally Disintegrating Meloxicam Tablets: Formulation and Evaluation

The aim of the present investigation was to formulate fast disintegrating tablets of meloxicam by wet granulation technique using medium molecular weight chitosan. The orally disintegrating tablets of meloxicam with chitosan showed good mechanical and disintegration properties and good dissolution rate when prepared in tablet press using 10.8 kN and 11.0 kN compression force. Chitosan is a suitable biopolymer to moderate the disintegration process in orally disintegrating tablets.

Biochar Tablets with and without Embedded Fertilizer on the Soil Chemical Characteristics and Nutrient Use Efficiency of Zea mays

Densification of ashy biochar into tablet can enhance the handling and conveyance efficiencies of biochar. It was hypothesized that fertilizer-embedded biochar tablets can slowly release embedded nutrients in synchrony with optimum nutrient uptake by crops. The objectives of this research were to determine the effects of biochar tablets with and without embedded fertilizer on soil chemical properties and nutrient use efficiency of Zea mays (sweet corn). The biochar tablet (BT) was produced by blending a biochar mixture with starch followed by densification using a single punch tablet press whereas the fertilizer embedded biochar tablet (BF) was prepared using the same procedure except that NPK fertilizer was added during blending. A pot experiment with five fertilization treatments including control was carried out in an open field located in Perlis, Malaysia. Co-application of biochar and fertilizer increased soil total carbon, nitrogen, but it reduced soil electrical conductivity (EC). Additionally, the BF significantly increased leaf chlorophyll content, dry root weight, and total plant nutrient use efficiency of sweet corn. The findings suggest that BF can serve as a slow release fertilizer to improve crop nutrient use efficiency. Therefore, embedding fertilizer in biochar tablets is recommended for sweet corn production following a long term field study to confirm the findings of this pot study.

Hydroxychloroquine Immediate Release Tablets: Formulation and Evaluation of a Solid Dosage Form

Hydroxychloroquine (HCQ) is a quinoline derivate used for the treatment of malaria and rheumatoid disorders. During early phases of the SARS-CoV2 (COVID-19) pandemic, preliminary and later not substantiated reports suggested that HCQ might benefit COVID-19 patients. This had sparked a worldwide and rapidly rising demand for HCQ drug products. Consequently, patients with pre-existing rheumatic diseases in Switzerland were confronted with an acute drug shortage.<br><br>We have therefore designed, produced and characterized a generic HCQ drug formulation. The proposed HCQ formulation can be manufactured by using a minimal number of operation steps (mixing, wet granulation, sieving, blending, compression) and readily available pharmaceutical excipients.<br><br>HCQ tablets were manufactured by granulation of the active pharmaceutical ingredient (API), blending with the external phase and compaction using a non instrumented single punch tablet press. Analytics and identification of the API was performed by a combination of NMR, ESI-MS, FTIR and HPLC. HCQ tablets met the quality criteria for an immediate release HCQ dosage form.<br><br><div>We hope that free access to non-proprietary protocols covering analytical procedures, formulation design, and manufacturing instructions for HCQ tablets will help to bridge existing and future supply chain gaps.</div><div><br></div><div><br></div>