Application of biopharmaceutical system of classification in development of new medicinal preparations

Gureyeva, S. N.; Albedhani, O. S.; Groschoviy, T. A.

doi:10.14739/2409-2932.2015.3.52383

Cited by 2 publications

(1 citation statement)

References 7 publications

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“…According to the scientific literature, the development of generic drugs on the pharmacological market currently surpasses that of original drugs owing to smaller financial and time expenses [ 29 ]. However, generic drugs do not always demonstrate sufficient clinical effectiveness.…”

Section: Discussionmentioning

confidence: 99%

A survey and optical microscopy in pilot comparative analysis of generic and original nimesulide granules

Leonenko

Ostanina

Kokoieva

et al. 2021

Heliyon

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Background: Secondary to increased development of generic nonsteroidal anti-inflammatory drugs (NSAIDs), there is a lack of simple and inexpensive ways of pilot detection of differences between the batches of generic drugs and the original ones. Objectives: To determine the peculiarities of the use of generic NSAIDs in routine practice through a pilot survey of dentists and to conduct a pilot comparative analysis of generic and original NSAIDs containing nimesulide granules using optical microscopy. Methods: The first part of the study included a pilot survey Convenience sampling of 192 dentists to study the use of generic NSAIDs in their routine practice. The second part included the use of a pilot optical microscopy of nimesulide particles isolated from four drugs: original drug (NA) and generic ones (NB, NC, ND). Results: In the questionnaires, dentists pointed to a 68.7% lower clinical efficacy and a 62.6% higher percentage of side effects of generic NSAIDs compared to the original ones. Based on the results of pilot optical microscopy, a statically significant difference in the size distribution of the drug substance particles in all generic nimesulide granules was determined as follows: NB (χ 2 : 15.15; p < 0.01); NC (χ 2 : 11.09; p < 0.05); ND (χ 2 : 1625.34; p < 0.001) compared with the original drug NA. Conclusions: A pilot survey of dentists showed that doctors noted the practical difference in the effects of the original and generic NSAIDs. A significant difference in the size of nimesulide particles and their distribution in generic drugs NB, NC, ND compared to the original NA suggests a possible difference in bioavailability and bioequivalence.

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Section: Discussionmentioning

confidence: 99%

A survey and optical microscopy in pilot comparative analysis of generic and original nimesulide granules

Leonenko

Ostanina

Kokoieva

et al. 2021

Heliyon

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Дослідження Профілів Розчинення Таблеток Амлодипіну З Еналаприлом

Behei¹,

Тригубчак²

2022

USMYJ

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quality assurance in the production of medicines is a comprehensive concept. The quality of medicines must be guaranteed at all stages of production - from development, research and production to implementation and optimal use. All this is included in the requirements of a number of good practices: GMP, GLP, GCP, GDP, GPP, GSP. Great importance in the development of solid dosage forms is given to the study of the degree of release rate of active substances and in environments with different acidity indicators. To assess the quality of the developed combined tablets of amlodipine with enalapril, to predict the rate of release of active substances from them, and accordingly the manifestation of therapeutic effect on the body, the aim was to study the dissolution profiles of amlodipine tablets with enalapril in comparison with the original drug, which contains one active substance. The subjects of the study were Amlodipine with enalapril, 5 mg / 5 mg tablets and the corresponding original monopreparations: Norvask, 5 mg tablets (amlodipine) and Berlipril, 5 mg tablets (enalapril). The studies were performed according to pharmacopoeial requirements using a device for dissolving USP I (shovels). Dissolution media - 900 ml of buffer solutions pH 1.2, pH 4.5 and pH 6.8. The analysis was performed by high performance liquid chromatography. A solution of potassium dihydrogen phosphate in water (pH 4.0) was used as the mobile phase. Detection was performed at a wavelength of 215 nm. Comparative studies of the dissolution kinetics of Amlodipine with enalapril, 5 mg / 5 mg tablets with the dissolution kinetics of the original Norvasc drugs, 5 mg tablets and Berlipril 5 mg tablets were performed. It was found that after 15 min in a pH of 6.8 enalapril maleate is released from the developed combination tablets by only 83.6%, and within 30 minutes there was a complete release of both active pharmaceutical ingredients in all study media. A high value of the factor of similarity of the dissolution profile of the developed drug Amlodipine with enalapril, tablets 5 mg / 5 mg to the original monopreparations: pH 1.2 amlodipine - 92.3, enalapril - 86.5; pH 4.5 amlodipine - 94.8, enalapril - 86.3; pH 6.8 amlodipine - 96.2, enalapril - 80.2. It was determined that the biopharmaceutical factors, which include the physicochemical properties of amlodipine and enalapril, the composition of excipients, features of the technological process, have an impact on the dissolution kinetics of the study drug based on amlodipine and enalapril. Therefore, the proposed combined tablets of amlodipine with enalapril are similar to the corresponding reference monopreparations and can find use in experimental and practical medicine.

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Application of biopharmaceutical system of classification in development of new medicinal preparations

Cited by 2 publications

References 7 publications

A survey and optical microscopy in pilot comparative analysis of generic and original nimesulide granules

A survey and optical microscopy in pilot comparative analysis of generic and original nimesulide granules

Дослідження Профілів Розчинення Таблеток Амлодипіну З Еналаприлом

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