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Orally disintegrating tablet of novel salt of antiepileptic drug: formulation strategy and evaluation.
Eur J Pharm Biopharm. 2013 Nov; 85(3 Pt B):1300-9.EJ

Abstract

The aim of present research was to design and evaluate orally disintegrating tablet (ODT) of novel lamotrigine-cyclamate salt. Box-Behnken response surface methodology was selected to design the optimized formulation. The independent factors selected were tablet hardness (X1), disintegrant (X2) and lubricant (X3) levels, and responses chosen were disintegration time (DT, Y1), friability (Y2), T50 (Y3), and T90 (Y4). The tablets were also characterized for drug uniformity by near infrared chemical imaging (NIR-CI) and taste masking evaluation by electronic tongue. All the selected independent variables were statistically (p<0.05) effect the Y1 while Y2, Y3, and Y4 affected only by X2. The optimized ODT was found to meet the regulatory requirement of DT and friability specification. The NIR-CI images indicated uniform distribution of active and inactive ingredients within the tablets. The electronic tongue results were analyzed by principle component analysis (PCA). It indicated that novel salt of lamotrigine and its ODT formulation have a taste similar to cyclamic acid which is indicated by close proximity on PCA score plot, lower Euclidean distance, and high discrimination index values. Furthermore, these parameters were very close to ODT placebo formulation. On the other hand, lamotrigine, its ODT, and placebo formulation were far from each other. In summary, lamotrigine salt provides another avenue for pediatric friendly formulation for children and will enhance patience compliance.

Authors+Show Affiliations

Division of Product Quality and Research, Center of Drug Evaluation and Research, Food and Drug Administration, MD, USA.No affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

23800704

Citation

Rahman, Ziyaur, et al. "Orally Disintegrating Tablet of Novel Salt of Antiepileptic Drug: Formulation Strategy and Evaluation." European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V, vol. 85, no. 3 Pt B, 2013, pp. 1300-9.
Rahman Z, Siddiqui A, Khan MA. Orally disintegrating tablet of novel salt of antiepileptic drug: formulation strategy and evaluation. Eur J Pharm Biopharm. 2013;85(3 Pt B):1300-9.
Rahman, Z., Siddiqui, A., & Khan, M. A. (2013). Orally disintegrating tablet of novel salt of antiepileptic drug: formulation strategy and evaluation. European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V, 85(3 Pt B), 1300-9. https://doi.org/10.1016/j.ejpb.2013.06.006
Rahman Z, Siddiqui A, Khan MA. Orally Disintegrating Tablet of Novel Salt of Antiepileptic Drug: Formulation Strategy and Evaluation. Eur J Pharm Biopharm. 2013;85(3 Pt B):1300-9. PubMed PMID: 23800704.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Orally disintegrating tablet of novel salt of antiepileptic drug: formulation strategy and evaluation. AU - Rahman,Ziyaur, AU - Siddiqui,Akhtar, AU - Khan,Mansoor A, Y1 - 2013/06/22/ PY - 2013/03/05/received PY - 2013/04/27/revised PY - 2013/06/04/accepted PY - 2013/6/27/entrez PY - 2013/6/27/pubmed PY - 2014/8/13/medline KW - Disintegration time KW - Dissolution KW - Electronic tongue KW - Lamotrigine-cyclamate salt KW - Near infrared chemical imaging KW - Orally disintegrating tablet SP - 1300 EP - 9 JF - European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V JO - Eur J Pharm Biopharm VL - 85 IS - 3 Pt B N2 - The aim of present research was to design and evaluate orally disintegrating tablet (ODT) of novel lamotrigine-cyclamate salt. Box-Behnken response surface methodology was selected to design the optimized formulation. The independent factors selected were tablet hardness (X1), disintegrant (X2) and lubricant (X3) levels, and responses chosen were disintegration time (DT, Y1), friability (Y2), T50 (Y3), and T90 (Y4). The tablets were also characterized for drug uniformity by near infrared chemical imaging (NIR-CI) and taste masking evaluation by electronic tongue. All the selected independent variables were statistically (p<0.05) effect the Y1 while Y2, Y3, and Y4 affected only by X2. The optimized ODT was found to meet the regulatory requirement of DT and friability specification. The NIR-CI images indicated uniform distribution of active and inactive ingredients within the tablets. The electronic tongue results were analyzed by principle component analysis (PCA). It indicated that novel salt of lamotrigine and its ODT formulation have a taste similar to cyclamic acid which is indicated by close proximity on PCA score plot, lower Euclidean distance, and high discrimination index values. Furthermore, these parameters were very close to ODT placebo formulation. On the other hand, lamotrigine, its ODT, and placebo formulation were far from each other. In summary, lamotrigine salt provides another avenue for pediatric friendly formulation for children and will enhance patience compliance. SN - 1873-3441 UR - https://www.unboundmedicine.com/medline/citation/23800704/Orally_disintegrating_tablet_of_novel_salt_of_antiepileptic_drug:_formulation_strategy_and_evaluation_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0939-6411(13)00224-5 DB - PRIME DP - Unbound Medicine ER -