The Influence of the Intergranular Superdisintegrant Performance on New Drotaverine Orodispersible Tablet Formulations
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 compress...
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| Format: | Article |
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MDPI AG
2023-08-01
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| Series: | Pharmaceutics |
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| Online Access: | https://www.mdpi.com/1999-4923/15/8/2147 |
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| author | Robert-Alexandru Vlad Cezara Pintea Diana-Andreea Chirteș Paula Antonoaea Emöke Margit Rédai Nicoleta Todoran Magdalena Bîrsan Adriana Ciurba |
| author_facet | Robert-Alexandru Vlad Cezara Pintea Diana-Andreea Chirteș Paula Antonoaea Emöke Margit Rédai Nicoleta Todoran Magdalena Bîrsan Adriana Ciurba |
| author_sort | Robert-Alexandru Vlad |
| collection | DOAJ |
| description | 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<sup>®</sup> 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. |
| first_indexed | 2024-03-10T23:39:33Z |
| format | Article |
| id | doaj.art-6b688dd0798c409c9c72c1d062d0f782 |
| institution | Directory Open Access Journal |
| issn | 1999-4923 |
| language | English |
| last_indexed | 2024-03-10T23:39:33Z |
| publishDate | 2023-08-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceutics |
| spelling | doaj.art-6b688dd0798c409c9c72c1d062d0f7822023-11-19T02:37:35ZengMDPI AGPharmaceutics1999-49232023-08-01158214710.3390/pharmaceutics15082147The Influence of the Intergranular Superdisintegrant Performance on New Drotaverine Orodispersible Tablet FormulationsRobert-Alexandru Vlad0Cezara Pintea1Diana-Andreea Chirteș2Paula Antonoaea3Emöke Margit Rédai4Nicoleta Todoran5Magdalena Bîrsan6Adriana Ciurba7Pharmaceutical Technology and Cosmetology Department, Faculty of Pharmacy, George Emil Palade University of Medicine, Pharmacy, Science and Technology of Targu Mures, 540142 Targu Mures, RomaniaFaculty of Pharmacy, George Emil Palade University of Medicine, Pharmacy, Science and Technology of Targu Mures, 540142 Targu Mures, RomaniaTargu Mures Clinical County Hospital, 540072 Targu Mures, RomaniaPharmaceutical Technology and Cosmetology Department, Faculty of Pharmacy, George Emil Palade University of Medicine, Pharmacy, Science and Technology of Targu Mures, 540142 Targu Mures, RomaniaPharmaceutical Technology and Cosmetology Department, Faculty of Pharmacy, George Emil Palade University of Medicine, Pharmacy, Science and Technology of Targu Mures, 540142 Targu Mures, RomaniaPharmaceutical Technology and Cosmetology Department, Faculty of Pharmacy, George Emil Palade University of Medicine, Pharmacy, Science and Technology of Targu Mures, 540142 Targu Mures, RomaniaDrug Industry and Pharmaceutical Biotechnology Department, Faculty of Pharmacy, “Grigore T. Popa” University of Medicine and Pharmacy from Iasi, 700115 Iasi, RomaniaPharmaceutical Technology and Cosmetology Department, Faculty of Pharmacy, George Emil Palade University of Medicine, Pharmacy, Science and Technology of Targu Mures, 540142 Targu Mures, RomaniaThe 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<sup>®</sup> 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.https://www.mdpi.com/1999-4923/15/8/2147intragranular superdisintegrantintergranular disintegrantfast-dissolving granulesdrotaverine orodispersible tabletspharmacotechnical evaluation |
| spellingShingle | Robert-Alexandru Vlad Cezara Pintea Diana-Andreea Chirteș Paula Antonoaea Emöke Margit Rédai Nicoleta Todoran Magdalena Bîrsan Adriana Ciurba The Influence of the Intergranular Superdisintegrant Performance on New Drotaverine Orodispersible Tablet Formulations Pharmaceutics intragranular superdisintegrant intergranular disintegrant fast-dissolving granules drotaverine orodispersible tablets pharmacotechnical evaluation |
| title | The Influence of the Intergranular Superdisintegrant Performance on New Drotaverine Orodispersible Tablet Formulations |
| title_full | The Influence of the Intergranular Superdisintegrant Performance on New Drotaverine Orodispersible Tablet Formulations |
| title_fullStr | The Influence of the Intergranular Superdisintegrant Performance on New Drotaverine Orodispersible Tablet Formulations |
| title_full_unstemmed | The Influence of the Intergranular Superdisintegrant Performance on New Drotaverine Orodispersible Tablet Formulations |
| title_short | The Influence of the Intergranular Superdisintegrant Performance on New Drotaverine Orodispersible Tablet Formulations |
| title_sort | influence of the intergranular superdisintegrant performance on new drotaverine orodispersible tablet formulations |
| topic | intragranular superdisintegrant intergranular disintegrant fast-dissolving granules drotaverine orodispersible tablets pharmacotechnical evaluation |
| url | https://www.mdpi.com/1999-4923/15/8/2147 |
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