Formulation development and optimization of bilayer tablets of aceclofenac

Dey, Sanjay; Mahanti, Beduin; Khila, Sudip; Mazumder, Bhaskar; Gupta, Sadipan Das

doi:10.1517/17425247.2012.707187

Cited by 21 publications

(9 citation statements)

References 10 publications

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“…DoE has been applied in many fields, including pharmaceutical product development [24][25][26][27][28]. It is gaining an increasing interest among pharmaceutical researchers, as more and more are becoming familiar with this approach, due to the relatively recent requirement for quality-by-design (QbD) principles.…”

Section: Employment Of Doe For the Development Of Novel Mlt Modified-mentioning

confidence: 99%

Per Os Administered Modified-Release Solid Formulations of Melatonin: A Review of the Latest Developments Including the Design of Experiments (DoE) Approach

Siamidi¹,

Dotsikas²

2020

Melatonin - The Hormone of Darkness and Its Therapeutic Potential and Perspectives

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The pineal hormone melatonin (MLT) is a derivative of the amino acid L-tryptophan and controls the circadian diurnal rhythm and the seasonal biorhythm. Exogenous administration is aimed at alleviating sleep-related dysfunctions and jet lag, as it decreases sleep-onset latency, increases total sleep time and improves overall sleep quality. Besides these indications, MLT has been shown to have other actions, such as antioxidant, immune enhancement and anticancer. It has also been shown to be useful against cardiovascular, neurological and psychiatric diseases. In the context of this work, a review of the related literature on the modified release of MLT from its per os administered formulations is presented, including the utilization of the design of experiments (DoE) for the selection of the optimal composition of melatonin formulations. The chapter offers an account of the recent advantages on MLT's solid dosage forms suitable for treating sleep disorders, referring either to its onset or maintenance.

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Section: Employment Of Doe For the Development Of Novel Mlt Modified-mentioning

confidence: 99%

Per Os Administered Modified-Release Solid Formulations of Melatonin: A Review of the Latest Developments Including the Design of Experiments (DoE) Approach

Siamidi¹,

Dotsikas²

2020

Melatonin - The Hormone of Darkness and Its Therapeutic Potential and Perspectives

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“…For convenience in formulation the doses were rounded to 2 and 11.5 mg (Dey et al, 2012;Robinson and Eriksen, 1966).…”

Section: Calculation Of Total Dose (Immediate Release Dose + Maintenamentioning

confidence: 99%

Development and In vitro-In vivo Characterization of Chronomodulated Multi-Particulate Drug Delivery System of Terbutaline Sulphate for Treatment of Nocturnal Asthma by box–Behnken Statistical Design

2017

J App Pharm Sci

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The objective of the present study was to develop a chronotherapeutic multi-particulate drug delivery system (CMPDDS) of Terbutaline sulphate (TS) intended for treatment of nocturnal asthma attacks. The formulation is capable of simultaneously releasing drug from an immediate release component and a sustain release component. In this study capsules containing immediate release powder blend and sustained release granules containing TS were formulated. Sustained release granules were formulated using Ethyl cellulose (EC), HPMC K15M, and Carbopol 971P. Optimization of sustained release granules was done by response surface methodology employing Box Behnken design. The CMPDDS were evaluated for physical characterization and In vitro drug release studies. The optimized CMPDDS formulation (MP1) was able to sustain the drug release for a period of 12 h. The accelerated stability studies showed no significant changes in physicochemical properties and release behaviour. Further in vivo pharmacokinetic studies were performed on rabbits to determine pharmacokinetic parameters. The formulation MP1 showed Cmax=169.87± 4.133 ng/mL at 4 h Tmax. The area under the curve for the formulation MP1 was 2079.95 ± 41.64 ng.h/mL. It can be concluded from the study that the CMPDDS of TS can be successfully formulated and used for the chronotherapy of nocturnal asthma.

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“…KBr background was obtained initially before analysis of test samples. The same procedures were repeated for the analysis of drug and for physical mixture of drug and excipients 9,10 .…”

Section: Fourier Transform Infrared (Ftir) Spectroscopymentioning

confidence: 99%

Effect of Different Grades of HPMC and Eudragit on Drug Release Profile of Doxofylline Sustained Release Matrix Tablets and Ivivc Studies

Panda¹,

Reddy²,

Reddy³

et al. 2015

Int. Res. J. Pharm.

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Present studies aimed for design of sustained release matrix tablets of Doxofylline through in vitro as well as pharmacokinetic studies that will reduce the frequency of dosing and improve patient compliance and to establish in vitro-in vivo correlation. Wet granulation methods were adopted using different grade of release retarding polymers HPMC and Eudragit in various proportion to optimise the release profile. Different precompression and post compression characterization of tablet was carried out and the results satisfied according to the pharmacopoeia specifications. In-vitro release studies were carried out in USP II paddle type dissolution apparatus for different formulations and the dissolution profiles of all the formulations were compared with standard marketed formulation by calculating the similarity factor (f2) and difference factor (f1). The formulation DSRF11 containing both the grades of HPMC (i.e HPMC K4M and HPMC K15M) having 7% each and 8% of Eudragit RSPO was considered as optimised formulation as the initial release was 18% and maximum release (99.19%) upto 12 h and showed highest f2 value (96.41) and lowest f1 value (0.88) was considered as optimised formulation. The hardness, friability, drug content and swelling index of DSRF11 found as 5.17±0.8 kg/cm 2 , 0.62±0.04, 102.35±1.44 and 96.29±2.16 respectively. The kinetic of in-vitro drug release profile of DSRF11 followed zero order kinetic model due to highest regression value (R 2 =0.993) having drug release mechanism as anomalous diffusion coupled with erosion (n=0.732). FTIR and DSC analysis revealed that there was no interaction between the drug and the polymers, thus these polymers can be conveniently used in development of Doxofylline sustained release matrix tablets. Accelerated stability studies of optimized formulation (DSRF11) showed a little change in physicochemical properties as well as drug release profiles at the end of 90 day indicating the stability of formulations. In vivo pharmacokinetic studies of optimised formulation and marketed standard formulation were carried out in New Zealand white rabbit and in vitro-in vivo correlation was established. Thus the current study clearly indicate a promising potential of the Doxofylline sustained release matrix tablets system as an alternative to the conventional dosage form as it control in vitro burst effect of the highly water-soluble drug, Doxofylline hydrochloride and can prevent in-vivo dose dumping.

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Formulation development and optimization of bilayer tablets of aceclofenac

Abstract: The double layer tablets for aceclofenac can be successfully employed as once-a-day oral-controlled release drug delivery system characterized by initial burst release of aceclofenac for providing the loading dose of drug.

Cited by 21 publications

References 10 publications

Per Os Administered Modified-Release Solid Formulations of Melatonin: A Review of the Latest Developments Including the Design of Experiments (DoE) Approach

Per Os Administered Modified-Release Solid Formulations of Melatonin: A Review of the Latest Developments Including the Design of Experiments (DoE) Approach

Development and In vitro-In vivo Characterization of Chronomodulated Multi-Particulate Drug Delivery System of Terbutaline Sulphate for Treatment of Nocturnal Asthma by box–Behnken Statistical Design

Effect of Different Grades of HPMC and Eudragit on Drug Release Profile of Doxofylline Sustained Release Matrix Tablets and Ivivc Studies

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