Physiochemical characterization of taste masking levetiracetam ion exchange resinates in the solid state and formulation of stable liquid suspension for pediatric use

Srinivasan, S.; Karthikeyan, E.; Veena, D; Chandana, P.J.; Sumana, P Sai; Subhashree, P; Ramya, L; Rajalakshmi, R.; Kumar, Ch. Kiran

doi:10.1016/j.bjbas.2016.04.004

Cited by 11 publications

(9 citation statements)

References 10 publications

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“…From the preformulation study, it was observed that majority of formulations exhibited fair angle of repose, reflecting excellent or good flow abilities as per USP general chapter [21]. However, the compressibility of blends were coming under fair (16)(17)(18)(19)(20) to passable (20-25) category. While there were variations in the bulk density of the formulations, the tapped density of all the formulations were found to be close to each other.…”

Section: Discussionmentioning

confidence: 99%

“…The alternative of administration of this medication is that the tablets may be crushed and placed in food or down a nasogastric tube for those unable to swallow whole tablets. If this is done, it leads to bitter taste resulting from exposing the drug powder [20]. Another option for administration of levetiracetam is oral solution dosage form.…”

Section: Introductionmentioning

confidence: 99%

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Application of response surface methodology (RSM) in statistical optimization and pharmaceutical characterization of a patient compliance effervescent tablet formulation of an antiepileptic drug levetiracetam

et al. 2020

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Background The main objective of the present study was to develop and optimize an effervescent tablet of levetiracetam, an antiepileptic drug, using central composite design with response surface methodology (RSM).The present investigation helps to overcome the problem associated with levetiracetam tablets and liquid dosage forms with children and elderly people like bad taste and swallowing difficulties. It also facilitates as an alternative manufacturing process for advanced patented technology like 3D printing process employed in SPRITAM® tablet. Levetiracetam effervescent tablets were prepared by dry granulation (roll compaction) method using water-soluble excipients and optimized by central composite rotatable design (CCRD) using two variables (citric acid and effersoda) at two levels (high and low). Overall, fourteen formulation trials were generated through statistical software Minitab 17.3.0 placing 6 center points, 4 cube points, and 4 axial points. All formulations were subjected to compression using single punch machine. Results Quality attributes of compressed tablets were evaluated using various compendial and non-compendial tests. RSM was used to observe the responses like effervescent time, hardness, and friability of the prepared tablet batches for different levels of all the variables. Polynomial equations were developed, and model plots (contour plot and 3-dimensional model surface plots) were generated to study the impact of acid-base couple on the responses. Finally, the optimized formulation was selected on the basis of desired effervescent time, hardness, friability, percent drug release, and drug content. From the studied RSM design, it was observed that small changes in the independent variables (citric acid and effersoda) correlate with shifts in the dependent variables, i.e., the desired responses. The study reveals that all the independent variables (citric acid and effersoda) and dependent variables (effervescent time, hardness, and friability) have a good correlation as indicated by good linear regression coefficient of 0.9808, 0.9939, and 0.9892 for effervescent time, hardness, and friability respectively. Conclusion Levetiracetam effervescent tablets are satisfactorily prepared by dry granulation (roll compaction) approach. All desired critical quality attributes were found to be satisfactory. The applicability of RSM with desirability function in optimizing the levetiracetam formulation has made it possible to identify the impact of various independent variables and explore their effect on required responses.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Application of response surface methodology (RSM) in statistical optimization and pharmaceutical characterization of a patient compliance effervescent tablet formulation of an antiepileptic drug levetiracetam

et al. 2020

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“…Drug loading in the prepared ion exchange resin complex was determined by analyzing the supernatant for the free drug by measuring uv absorbance of drug at 250 nm, then the amount of valsartan loaded into complexes was determined from the difference between the initial and free amount of valsartan in the supernatant [3] .…”

Section: Valsartan Content and Loading Percentmentioning

confidence: 99%

“…➢ Dissolution studies in Buffer Solution pH 1.2 (stomach media) United States Pharmacopoeia dissolution apparatus (type II) was used to study the release of valsartan from DRC at pH 1.2 dissolution media. Accurately weighted amount of DRC equivalent to 40 mg of valsartan was added to 900 ml (pH 1.2 dissolution media) that maintained at 37±0.5° C [3] . Dissolution medium was rotated at 50 rpm and the release of drug was tested for 2 hours.…”

Section: Studies On Drug-resin Complex 251 In-vitro Dissolution Studi...mentioning

confidence: 99%

“…Several taste masking methods are available such as chemical modification (like a prodrug), coating the particle surface, physical masking by additives and using of ion exchange resins [1]. Ionexchange resins are widely utilized in the formulation of bitter drugs for oral use like taste masking of clarithromycin and ‫لي*‬ ‫كمال‬ ‫وداد‬ levetiracetam [2,3]. These agents adsorb on drug surface and hide the bitter taste.…”

Section: Introductionmentioning

confidence: 99%

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Preparation and characterization of taste masked valsartan by ion-exchange resin approach

Mohammed

Ali

2018

AJPS

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The bitter taste is one of the most important drug formulation problems. The unpleasant taste leads to noncompliance, which consequently decreases the therapeutic efficacy of the drug. Therefore, masking of bitter taste is very important in drug formulation. In this study an antihypertensive drug, valsartan, which is a weak acid with bitter taste, was used as a model drug to mask its taste with dowex2 (weak base anion exchange resin). The taste masking of a drug using ion exchange resin basically depends on the complex formation between the drug and a specific type of resin. Complex formation under various preparation conditions including; the ratio of drug to resin, mixing time, the pH of the processing medium and the concentration of valsartan was investigated in this study. Optimum conditions for complex formation and maximum drug load were obtained at a drug-resin ratio 1:8, mixing time 4 hours, pH 6.8, temperature 50º C and drug concentration 0.02% w/v. The drug resinate complex was evaluated for the drug content, taste, drug release and molecular properties. The resinate formation was confirmed using different analytical techniques like thermal analysis using differential scanning calorimetry (DSC), spectroscopic method like Fourier transform infrared spectroscopy (FTIR) and by X-ray powder diffraction analysis (XRPD).

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Graphene oxide in the production of ion-exchange membranes for electrodialysis cells

et al. 2023

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Physiochemical characterization of taste masking levetiracetam ion exchange resinates in the solid state and formulation of stable liquid suspension for pediatric use

Cited by 11 publications

References 10 publications

Application of response surface methodology (RSM) in statistical optimization and pharmaceutical characterization of a patient compliance effervescent tablet formulation of an antiepileptic drug levetiracetam

Application of response surface methodology (RSM) in statistical optimization and pharmaceutical characterization of a patient compliance effervescent tablet formulation of an antiepileptic drug levetiracetam

Preparation and characterization of taste masked valsartan by ion-exchange resin approach

Graphene oxide in the production of ion-exchange membranes for electrodialysis cells

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