Development and Evaluation of Raft Forming Gastro Retentive Floating Drug Delivery System of Nizatidine by Design of Experiment

SAGAR, SHANTI

doi:10.22159/ijap.2022v14i2.43728

Cited by 5 publications

(8 citation statements)

References 14 publications

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“…Ink). By contrasting various polynomial models' coefficients of variation, predicted and adjusted multiple correlation coefficients, and lack-of-fit statistics, the bestfitting polynomial models were determined [20]. A significant difference was found using analysis of variance.…”

Section: Discussionmentioning

confidence: 99%

Box-Behnken Design for Optimization of Formulation Variables for Controlled Release Gastroretentive Tablet of Verapamil Hydrochloride

ARPNA

MASHEER²

2023

Int J App Pharm

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Objective: To develop a Verapamil hydrochloride controlled release gastro-retentive (CRGR) tablet for once-daily dosing using the response surface Box-Behnken Design (BBD) approach for the improvement of bioavailability and reduction in dosing frequency to overcome the issues related to the conventional tablet formulation. Methods: For the optimization, 33Box-Behnken design was used. The independent variables were selected, the amount of Compritol 888 ATO (A), HPMC K15M (B), and Sodium bicarbonate (C). The dependent variables were Cumulative % drug release in 1.5 h (Q1.5), 8 h (Q8), 24 H (Q24) and floating lag time (FLT). Flow properties of pre-compressed powder, physical characteristics, drug content, floating lag time, total floating time and in vitro dissolution study of all formulation were assessed. In vitro dissolution study of optimized formulation that was prepared experimentally was performed and compared with predicted data obtained from the software. Drug release kinetics of the optimized formulation was also assessed to know the mechanism of drug release from the CRGR tablets. Results: Responses of experimental runs were found as Q1.5: 12.78-33.62 (%), Q8: 43.03-64 (%), Q24: 78.77 to 103.57 (%) and floating lag time as 3.01 min to 5.08 min. The predicted optimized formula with the highest desirability value of 0.963 containing amount 126.030 mg, 160.00 mg and 80.955 mg of Compritol 888 ATO, HPMC K15M and Sodium biarbonate respectively was prepared and evaluated. The experimental values from optimized formulation were obtained as Q1.5: 23.397%, Q8; 57.744%, Q24: 97.150% and FLT: 3.12 min. Predicted and experimental results were found comparable for all the responses. The release data from the optimized formulation were best fitted in the Higuchi (r2 = 0.999) and the Korsmeyer-Peppas ((r2 = 0.998, n=0.54) model. The in vitro drug release studies indicated that the Verapamil hydrochloride gastroretentive tablet releases the drug in controlled manner for 24 h. Conclusion: This study found that using Box-Behnken Design with the response and variable relation, it is possible to achieve an optimum formulation with desirable characteristics. This study also established the suitability of Compritol 888 ATO-HPMC K15M combination with Sodium bicarbonate to increase the gastric residence time tablet formulation had once-daily dosing of the Verapamil Hcl with improved bioavailability for effective management of hypertension.

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Section: Discussionmentioning

confidence: 99%

Box-Behnken Design for Optimization of Formulation Variables for Controlled Release Gastroretentive Tablet of Verapamil Hydrochloride

ARPNA

MASHEER²

2023

Int J App Pharm

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“…The resistant flow property (viscosity) of In situ gel formulations was determined at room temperature using a Brookfield viscometer type DV-II+PRO (LV1 Spindle) [11].…”

Section: Viscositymentioning

confidence: 99%

“…Take a 50 ml volume of 0.1N HCl in a measuring beaker and add 30 ml in situ formulated gel. The amount of gel formed was transferred to the measuring cylinder and weight is measured by using the volume and weight of the gel; the density is calculated using the formula [11].…”

Section: Measurement Of Densitymentioning

confidence: 99%

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Formulation Development and Characterization of Lafutidine Raft System

SAGAR

PRAMODINI²

2023

Int J Pharm Pharm Sci

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Objective: The present research work is focused to develop in situ raft gel of lafutidine. Sodium alginate is one of the critical components for the development in situ raft system. Methods: The formulation was prepared using hydrophilic polymers such as ethyl cellulose, HPMC K4M, and chitosan. The formulations were subjected to evaluation characteristics such as pH, in vitro gelling time, viscosity, density, gel strength, drug-polymer compatibility studies, drug content floating lag time, swelling index, and in vitro release studies. Results: The pH of all the prepared batches was found in the range of 5.7 to 7.6. All the prepared formulations showed viscosity in the range of 264 to 320 cps, with gelling time from 4-7 s. For F1-F15 batches Floating lag time was found to be in the range of 9-24 sec. Densities of all formulations stomach specific in situ gels were in the range of 0.4 to 0.8 gm/cm3. The highest swelling index was observed in F15 with 14.16% Highest gel strength is exhibited by F15; all the formulations were in the range of 95.46–99.95, indicating the uniform distribution of the drug. Formulation F15 containing chitosan in combination with ethyl cellulose gave the highest drug release of 99.78% and also showed sustained and controlled release for up to 24h. Conclusion: F15 shows an R2 value of 0.999. As its value is nearer to the ‘1’ it is confirmed as it follows the Zero order release with an ‘n’ value is 1.5021 for the optimized formulation (F15) i.e., the n value indicates super case II transport and is considered as optimized formulation.

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“…If the p-value was less than the cutoff (p = 0.05), it was declared significant. The DOE (design of experiments) studies' statistical analysis was performed using design-expert ® software (11.0), Fractional factorial design (2 2 +3) with 3 center points [36,37]. Additionally, the half-normal plot is used to evaluate and choose significant components based on desired linearity and any remaining experimental data, if it is available.…”

Section: In Vitro Dissolution Study For Formulation and Process Varia...mentioning

confidence: 99%

A QBD With the Fractional Factorial Design Was Used to Match the Similarity Between Ranolazine Extended-Release Tablets 500 Mg and 1000 Mg

et al. 2023

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Objective: Formulation and development of Ranolazine extended-release Tablets 500 mg and 1000 mg by using QBD with Fractional factorial design to match the similarity with Branded formulation (RANEXA®). Methods: Ranolazine extended-release tablets were developed by using various polymers, Polyquid PA100 and ETHOCEL TMstandard 7 premium and Hypromellose with a wet granulation process. QBD (Quality by Design) approach was used to identify the formulation and process variables that may affect the CQAs (critical quality attributes). Excipient compatibility studies were conducted to identify the interaction between API (active pharmaceutical ingredient) and selected excipients. Additionally, using a two-level, fractional factorial (22+3) design, the DOE (design of experiments) was employed to confirm the impacts of key process factors (fluid uptake and kneading time) on the formulation's ability to match the dissolution (f2) compared to RLD (reference listed drug) and establish a stable formulation. Results: Initial risk assessment was carried out to identify the various attributes such as API flow properties, solubility, PSD, Hygroscopicity, formulation, and process variables to impact the quality of the drug product. Flow properties of API indicate poor flow. Drug and excipients compatible study results indicate that excipients used in the compatibility study are considered compatible with the active ingredient. As per the saturation solubility studies and sink conditions, dissolution media was selected. Significant differences were found among the drug release profile by examining the various levels of polymers and binders. Using a two-level, fractional factorial (22+3) design, optimum process parameters were identified with selected formulation to match the dissolution (f2) similarity with the reference listed drug (RLD); finally, XRD (X-ray diffraction) studies confirm that the crystalline polymorphic forms (Form 1) peaks in optimum formulation (F07) comparable to the reference listed drug. Conclusion: Optimized formulation and process were established with QbD (quality by design) that provides the consistent drug release to match the f2 similarities with the extended-release tablets of RANEXA®(Ranolazine) 500 mg and 1000 mg.

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Development and Evaluation of Raft Forming Gastro Retentive Floating Drug Delivery System of Nizatidine by Design of Experiment

Cited by 5 publications

References 14 publications

Box-Behnken Design for Optimization of Formulation Variables for Controlled Release Gastroretentive Tablet of Verapamil Hydrochloride

Box-Behnken Design for Optimization of Formulation Variables for Controlled Release Gastroretentive Tablet of Verapamil Hydrochloride

Formulation Development and Characterization of Lafutidine Raft System

A QBD With the Fractional Factorial Design Was Used to Match the Similarity Between Ranolazine Extended-Release Tablets 500 Mg and 1000 Mg

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