Formulation and evaluation of orally disintegrating clopidogrel tablets
ABSTRACT Recent advances in drug delivery systems have aimed to achieve better patient compliance. One of these advances is the formulation of orally disintegrating tablets (ODTs) that dissolve instantaneously, releasing drugs within a few seconds without the need of water. The main objective of thi...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
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Universidade de São Paulo
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| Series: | Brazilian Journal of Pharmaceutical Sciences |
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| Online Access: | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502016000200309&lng=en&tlng=en |
| _version_ | 1818384885480423424 |
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| author | Gamal Mohamed Mahrous Mohamed Gabr Kassem Mohamed Abbas Ibrahim Sayed Hassan Auda |
| author_facet | Gamal Mohamed Mahrous Mohamed Gabr Kassem Mohamed Abbas Ibrahim Sayed Hassan Auda |
| author_sort | Gamal Mohamed Mahrous |
| collection | DOAJ |
| description | ABSTRACT Recent advances in drug delivery systems have aimed to achieve better patient compliance. One of these advances is the formulation of orally disintegrating tablets (ODTs) that dissolve instantaneously, releasing drugs within a few seconds without the need of water. The main objective of this paper was to prepare and develop ODTs of clopidogrel. The ODTs were prepared by direct compression. The effect of three superdisintegrants, namely crospovidone, croscarmellose sodium, and sodium starch glycolate, using three different disintegration times on the dissolution rate was investigated. The prepared tablets were evaluated for hardness, friability, disintegration time and in vitro drug release. Furthermore, the interaction of clopidogrel with the formulation excipients was studied using differential scanning calorimetry (DSC). DSC studies revealed that there were no interactions between the drug and the excipients used. All tablets had hardness values in the range 4.0-5.2 kp and friability lower than 1%. The weight and drug content uniformity of all formulations was within official limits according to BP. In vitro drug release studies of the ODTs showed that more than 90% of the drug was released within ten minutes. A palatability test in human volunteers showed acceptable taste and mouth feel. Thus, the obtained results conclusively demonstrated successful rapid disintegration of the formulated tablets and acceptable palatability. |
| first_indexed | 2024-12-14T03:29:22Z |
| format | Article |
| id | doaj.art-7eb2142d22e14b32bd5ab5b967f8f0f6 |
| institution | Directory Open Access Journal |
| issn | 2175-9790 |
| language | English |
| last_indexed | 2024-12-14T03:29:22Z |
| publisher | Universidade de São Paulo |
| record_format | Article |
| series | Brazilian Journal of Pharmaceutical Sciences |
| spelling | doaj.art-7eb2142d22e14b32bd5ab5b967f8f0f62022-12-21T23:18:48ZengUniversidade de São PauloBrazilian Journal of Pharmaceutical Sciences2175-979052230931810.1590/S1984-82502016000200009S1984-82502016000200309Formulation and evaluation of orally disintegrating clopidogrel tabletsGamal Mohamed MahrousMohamed Gabr KassemMohamed Abbas IbrahimSayed Hassan AudaABSTRACT Recent advances in drug delivery systems have aimed to achieve better patient compliance. One of these advances is the formulation of orally disintegrating tablets (ODTs) that dissolve instantaneously, releasing drugs within a few seconds without the need of water. The main objective of this paper was to prepare and develop ODTs of clopidogrel. The ODTs were prepared by direct compression. The effect of three superdisintegrants, namely crospovidone, croscarmellose sodium, and sodium starch glycolate, using three different disintegration times on the dissolution rate was investigated. The prepared tablets were evaluated for hardness, friability, disintegration time and in vitro drug release. Furthermore, the interaction of clopidogrel with the formulation excipients was studied using differential scanning calorimetry (DSC). DSC studies revealed that there were no interactions between the drug and the excipients used. All tablets had hardness values in the range 4.0-5.2 kp and friability lower than 1%. The weight and drug content uniformity of all formulations was within official limits according to BP. In vitro drug release studies of the ODTs showed that more than 90% of the drug was released within ten minutes. A palatability test in human volunteers showed acceptable taste and mouth feel. Thus, the obtained results conclusively demonstrated successful rapid disintegration of the formulated tablets and acceptable palatability.http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502016000200309&lng=en&tlng=enClopidogrel/orally disintegrating tabletsSuperdisintegrantsOrally disintegrating tablets/formulationOrally disintegrating tablets/evaluation |
| spellingShingle | Gamal Mohamed Mahrous Mohamed Gabr Kassem Mohamed Abbas Ibrahim Sayed Hassan Auda Formulation and evaluation of orally disintegrating clopidogrel tablets Brazilian Journal of Pharmaceutical Sciences Clopidogrel/orally disintegrating tablets Superdisintegrants Orally disintegrating tablets/formulation Orally disintegrating tablets/evaluation |
| title | Formulation and evaluation of orally disintegrating clopidogrel tablets |
| title_full | Formulation and evaluation of orally disintegrating clopidogrel tablets |
| title_fullStr | Formulation and evaluation of orally disintegrating clopidogrel tablets |
| title_full_unstemmed | Formulation and evaluation of orally disintegrating clopidogrel tablets |
| title_short | Formulation and evaluation of orally disintegrating clopidogrel tablets |
| title_sort | formulation and evaluation of orally disintegrating clopidogrel tablets |
| topic | Clopidogrel/orally disintegrating tablets Superdisintegrants Orally disintegrating tablets/formulation Orally disintegrating tablets/evaluation |
| url | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502016000200309&lng=en&tlng=en |
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