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Pharmaceutics
Volume 15
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10.3390/pharmaceutics15082147
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Article

The Influence of the Intergranular Superdisintegrant Performance on New Drotaverine Orodispersible Tablet Formulations

by
Robert-Alexandru Vlad
1,†,
Cezara Pintea
2,†,
Diana-Andreea Chirteș
3,†,
Paula Antonoaea
1,*,
Emöke Margit Rédai
1,*,
Nicoleta Todoran
1,
Magdalena Bîrsan
4 and
Adriana Ciurba
1
1
Pharmaceutical Technology and Cosmetology Department, Faculty of Pharmacy, George Emil Palade University of Medicine, Pharmacy, Science and Technology of Targu Mures, 540142 Targu Mures, Romania
2
Faculty of Pharmacy, George Emil Palade University of Medicine, Pharmacy, Science and Technology of Targu Mures, 540142 Targu Mures, Romania
3
Targu Mures Clinical County Hospital, 540072 Targu Mures, Romania
4
Drug Industry and Pharmaceutical Biotechnology Department, Faculty of Pharmacy, “Grigore T. Popa” University of Medicine and Pharmacy from Iasi, 700115 Iasi, Romania
*
Authors to whom correspondence should be addressed.
†
These authors contributed equally to this work.
Pharmaceutics 2023, 15(8), 2147; https://doi.org/10.3390/pharmaceutics15082147
Submission received: 24 July 2023 / Revised: 13 August 2023 / Accepted: 14 August 2023 / Published: 16 August 2023
(This article belongs to the Special Issue Carbohydrate-Based Carriers for Drug Delivery)
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Abstract

The main objective of this study consists in establishing the influence of the intergranular superdisintegrant on the specific properties of drotaverine hydrochloride fast-dissolving granules (DROT-FDGs) and orodispersible tablets (DROT-ODTs). The orodispersible tablets were obtained by the compression of the FDGs and excipient mixture with an eccentric tableting machine. To develop DROT-ODTs, two types of superdisintegrant excipients in different concentrations (water-soluble soy polysaccharides (SSP) (1%, 5%) and water-insoluble soy polysaccharides—Emcosoy® STS IP (EMCS) (1%, 3%, 5%)) were used, resulting in five formulations (D1–D5). The DROT-FDGs and the DROT-ODTs were subjected to pharmacotechnical and analytical evaluation. All the orodispersible tablets obtained respect the quality requirements in terms of friability (less than 1%), crushing strength (ranging between 52 N for D2 and 125.5 N for D3), and disintegration time (<180 s). The in vitro release of drotaverine from ODTs showed that all formulations presented amounts of active substance released greater than 85% at 10 min. The main objective, developing 30 mg DROT-ODTs for children aged between 6 and 12 years by incorporating the API in FDGs, was successfully achieved.
Keywords: intragranular superdisintegrant; intergranular disintegrant; fast-dissolving granules; drotaverine orodispersible tablets; pharmacotechnical evaluation intragranular superdisintegrant; intergranular disintegrant; fast-dissolving granules; drotaverine orodispersible tablets; pharmacotechnical evaluation

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MDPI and ACS Style

Vlad, R.-A.; Pintea, C.; Chirteș, D.-A.; Antonoaea, P.; Rédai, E.M.; Todoran, N.; Bîrsan, M.; Ciurba, A. The Influence of the Intergranular Superdisintegrant Performance on New Drotaverine Orodispersible Tablet Formulations. Pharmaceutics 2023, 15, 2147. https://doi.org/10.3390/pharmaceutics15082147

AMA Style

Vlad R-A, Pintea C, Chirteș D-A, Antonoaea P, Rédai EM, Todoran N, Bîrsan M, Ciurba A. The Influence of the Intergranular Superdisintegrant Performance on New Drotaverine Orodispersible Tablet Formulations. Pharmaceutics. 2023; 15(8):2147. https://doi.org/10.3390/pharmaceutics15082147

Chicago/Turabian Style

Vlad, Robert-Alexandru, Cezara Pintea, Diana-Andreea Chirteș, Paula Antonoaea, Emöke Margit Rédai, Nicoleta Todoran, Magdalena Bîrsan, and Adriana Ciurba. 2023. "The Influence of the Intergranular Superdisintegrant Performance on New Drotaverine Orodispersible Tablet Formulations" Pharmaceutics 15, no. 8: 2147. https://doi.org/10.3390/pharmaceutics15082147

APA Style

Vlad, R.-A., Pintea, C., Chirteș, D.-A., Antonoaea, P., Rédai, E. M., Todoran, N., Bîrsan, M., & Ciurba, A. (2023). The Influence of the Intergranular Superdisintegrant Performance on New Drotaverine Orodispersible Tablet Formulations. Pharmaceutics, 15(8), 2147. https://doi.org/10.3390/pharmaceutics15082147

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