Dissolution Testing of Orally Disintegrating Tablets

Klancke, James

doi:10.14227/dt100203p6

Cited by 81 publications

(53 citation statements)

References 5 publications

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“…The authors reported that a 2-fold increase in CF caused approximately a 5-fold increase in the tablet crushing strength to 130 N, and a 2-fold increase in DT to 78 seconds. Commercially available ODT tablets have diameters ranging from 9 mm to 17.5 mm and at the larger diameters of13 mm and greater, they can accommodate higher drug dosage of 100mg (El-Arini and Clas, 2002;Klancke, 2003;McLaughlin et al, 90 2009) (Table 1). …”

Section: Introductionmentioning

confidence: 99%

Application of face centred central composite design to optimise compression force and tablet diameter for the formulation of mechanically strong and fast disintegrating orodispersible tablets

Pabari¹,

Ramtoola²

2012

International Journal of Pharmaceutics

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Section: Introductionmentioning

confidence: 99%

Application of face centred central composite design to optimise compression force and tablet diameter for the formulation of mechanically strong and fast disintegrating orodispersible tablets

Pabari¹,

Ramtoola²

2012

International Journal of Pharmaceutics

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“…Typically, the dissolution of ODTs is very fast when using USP monograph conditions. Hence, lower paddle speeds might yield more discriminating dissolution profiles (Klancke, 2003;Battu et al, 2007). Therefore, in vitro dissolution studies were also conducted at a lower paddle speed of 25 rpm to select the optimized ODT formulation.…”

Section: In Vitro Dissolution Studiesmentioning

confidence: 99%

Formulation and in vivo evaluation of ondansetron orally disintegrating tablets using different superdisintegrants

et al. 2011

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The aim of this study was to formulate cost effective taste-masked orally disintegrating tablets of ondansetron, a bitter drug using different superdisintegrants by a wet granulation technique. Microcrystalline cellulose (Avicel) as a diluent and disintegrant in addition to aspartame as a sweetener were used in all formulations. The prepared tablets were evaluated for weight variation, thickness, hardness, friability, drug content, water content, in vitro disintegration time and in vitro drug release. The tablets' hardness was maintained in the range of 2-3 kg and friability was <1% for all batches. All tablet formulations disintegrated rapidly in vitro within 5.83 to 33.0 sec. The optimized formulation containing 15% Polyplasdone XL-10 released more than 90% of drug within 5 min and the release was comparable to that of a commercial product. In human volunteers, optimized formulation was found to have a pleasant taste and mouth feel and they disintegrated in the oral cavity within 12 sec. The stability results were also satisfactory. A pharmacokinetic study with the optimized formulation was performed in comparison with a reference (Zofer MD 8®) and they were found to be bioequivalent. In conclusion, a cost effective ondansetron orally disintegrating tablet was successfully prepared with acceptable hardness, desirable taste and rapid disintegration in the oral cavity.

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“…It is apparent that in the first 5 min, 89.0 ± 3.7 % of the drug was dissolved in the medium which increased to 94.1 ± 0.6 % in 15 min. According to the literature, the amount of drug dissolved from sublingual tablets must exceed 80 % in 15 min (20). Thus, the prepared optimized tablet met the above mentioned dissolution requirement.…”

Section: Drug Content and Dissolution Studiesmentioning

confidence: 99%

Development and optimization of a sublingual tablet formulation for physostigmine salicylate

Bolourchian¹,

Hadidi²,

Foroutan³

et al. 2009

Acta Pharmaceutica

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Physostigmine salicylate, a reversible inhibitor of cholinesterase activity (1) may be an effective drug in the management of Alzheimer's disease (2, 3) and may be also used in the treatment of nerve gas poisoning (2). It is readily absorbed from the gastrointestinal tract (1) and undergoes extensive presystemic metabolism (2), which results in poor bioavailability of its oral dosage forms (2, 3). Short elimination half-life of this drug (3) makes repeated injections at short time intervals necessary and causes poor patient compliance. Therefore preparation of a suitable and more effective dosage form of this drug is needed. This study is aimed to design and optimize a sublingual tablet formulation of physostigmine salicylate, an effective drug in Alzheimer's disease and nerve gas poisoning, by means of the D-optimal experimental design methodology. Polyvinyl pyrrolidone, lactose, starch 1500 and sodium starch glycolate were used in the formulations as independent variables. Tablets were prepared by the direct compression method and evaluated for their physical properties (tablet hardness, disintegration time and friability), which were regarded as responses in a D-optimal design. Due to the significance of the special cubic model for data fitted, compared to other models, it was used to examine the obtained results. Response surface plots were plotted to study the tablet properties and the optimized overlay plot was generated based on the results and targets considered for the responses. After verification of the optimum checkpoint formulations, an optimized formulation was chosen due to its desirable physical properties and closely observed and predicted values. Drug assay, content uniformity of the dosage unit, drug dissolution and accelerated stability studies were done on the optimum formulation as further experiments. All the obtained results complied with the requirements of a sublingual tablet formulation.

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Dissolution Testing of Orally Disintegrating Tablets

Cited by 81 publications

References 5 publications

Application of face centred central composite design to optimise compression force and tablet diameter for the formulation of mechanically strong and fast disintegrating orodispersible tablets

Application of face centred central composite design to optimise compression force and tablet diameter for the formulation of mechanically strong and fast disintegrating orodispersible tablets

Formulation and in vivo evaluation of ondansetron orally disintegrating tablets using different superdisintegrants

Development and optimization of a sublingual tablet formulation for physostigmine salicylate

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