FORMULATION DEVELOPMENT AND EVALUATION OF IMMEDIATE RELEASE BILAYER TABLETS OF TELMISERTAN AND HYDROCHLOROTHIAZIDE

The main goal of this study was to develop a stable formulation of antihypertensive drugs telmisartan and hydrochlorothiazide as an immediate-release bilayer tablet and to evaluate the dissolution profile in comparison with a reference product. The formulation development work was initiated with wet granulation. Telmisartan was converted to its sodium salt by dissolving in aqueous solution of sodium hydroxide to improve solubility and drug release. Lactose monohydrate and microcrystalline cellulose were used as diluents. Starch paste is prepared in purified water and was used as the binder. Sodium starch glycolate is added as a disintegrating agent. Magnesium stearate was used as the lubricant. The prepared granules were compressed into a double-layer compression machine. The tablets thus formulated with higher proportion of sodium starch glycolate showed satisfactory physical parameters, and it was found to be stable and in vitro release studies are showed that formulation (F-T5H5) was 101.11% and 99.89% respectively. The formulation T5H5 is further selected and compared with the release profile of the innovator product, and was found to be similar (f2 factor) to that of the marketed product. The results suggest the feasibility of developing bilayer tablets consisting of telmisartan and hydrochlorothiazide for the convenience of patients with hypertension.

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Formulation, Development and Evaluation of Bilayer Tablet of Flurbiprofen

International Journal of Scientific Research in Science and Technology ◽

10.32628/ijsrst196130 ◽

2019 ◽

pp. 246-251

Author(s):

Nitin A Gaikwad ◽

Indrjeet V Mane ◽

Manohar D Kengar ◽

Ranjeet S Jadhav

Keyword(s):

Immediate Release ◽

Wet Granulation ◽

Content Uniformity ◽

Formulation Development ◽

Sodium Starch Glycolate ◽

Bilayer Tablets ◽

Bilayer Tablet ◽

Weight Variation ◽

Initial Release ◽

Higuchi Model

In the Study of Formulation of Bilayer Tablet of Flurbiprofen the Following Materials Using sodium starch glycolate as immediate release and HPMC K15 in different ratios as release retardant materials using a wet granulation method. All tablets exhibited good physical properties with Respect to appearance, content uniformity, hardness, weight variation and Invitro dissolution data show at increasing proportions Of sodium starch glycolate for immediate release whereas HPMC K15sustaineddrugreleaserate. The bilayer tablets showed an initial release of drug In about1hr, then sustaining the release for 12h, The kinetic analysis of dissolution data showed that release was observe din these tablets. When data was fitted to the Higuchi model. Bilayer tablets of flurbiprofen can be successfully formulated Using sodium starch glycolate and HPMC K15 in different ratios as release retardant materials employing a wet granulation method.

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Formulation and In Vitro Evaluation of Bilayer Tablets of Lansoprazole and Amoxycillin Trihydrate for the Treatment of Peptic Ulcer

Journal of Drug Delivery and Therapeutics ◽

10.22270/jddt.v11i1.4481 ◽

2021 ◽

Vol 11 (1) ◽

pp. 23-31

Author(s):

Neha Singh ◽

Durga Pandey ◽

Nilesh Jain ◽

Surendra Jain

Keyword(s):

Sustained Release ◽

Immediate Release ◽

Flow Property ◽

Wet Granulation ◽

Formulation Development ◽

In Vitro Evaluation ◽

Bilayer Tablets ◽

Bilayer Tablet ◽

Sustained Release Tablets

The present work involves the formulation development, optimization and In-vitro evaluation of bilayer tablet containing Lansoprazole in the immediate release layer and Amoxycillin in the sustained release layer, using sodium starch glycolate as a super disintegrant for the immediate release layer and the hydrophilic matrix HPMC K100M, hydrophobic matrix Ethyl cellulose are used in the sustained release layer. Bilayer tablet showed as initial burst effect to provide dose of immediate release layer Lansoprazole to control the acid secretion level and the sustained release of Amoxycillin for 24 hours. Immediate and sustained release tablets were formulated by wet granulation method because of the poor flow property of the blends. The prepared bilayer tablet was evaluated for their precompression parameters, physical characteristics like hardness, friability, uniformity of weight, uniformity of drug content, swelling index, In-vitro floating studies and In-vitro drug release. The release of the lansoprazole from the immediate release layer was found to be 97.46 ± 0.15% in 15minutes. The release of Amoxycillin Trihydrate for the sustained release floating layer was found to be 98.25 ± 0.14% in 12 hours. Lansoprazole potentiate the effect of Amoxycillin. Hence the bilayer tablets of Lansoprazole and Amoxycillin were used to improve patient compliance towards the effective management of ulcer. Keywords: bilayer tablet, Lansoprazole, and Amoxycillin, sustained release

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Bilayer tablets with sustained-release metformin and immediate-release sitagliptin: preparation and in vitro/in vivo evaluation

Journal of Pharmaceutical Investigation ◽

10.1007/s40005-021-00533-z ◽

2021 ◽

Author(s):

Ngoc Nha Thao Nguyen ◽

Duy Toan Pham ◽

Duc Tuan Nguyen ◽

Thi Thu Loan Trinh

Keyword(s):

Sustained Release ◽

Immediate Release ◽

In Vivo Evaluation ◽

Bilayer Tablets

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Formulation, Development and Evaluation of Bilayer Floating Tablet of Gemfibrozil

Journal of Drug Delivery and Therapeutics ◽

10.22270/jddt.v9i4-s.3401 ◽

2019 ◽

Vol 9 (4) ◽

pp. 574-578

Author(s):

Mohammad Faizan Mohammad Gufran ◽

Sailesh Kumar Ghatuary ◽

Reena Shende ◽

Prabhat Kumar Jain ◽

Geeta Parkhe

Keyword(s):

Drug Release ◽

Sustained Release ◽

Hydroxypropyl Methylcellulose ◽

Immediate Release ◽

In Vitro Dissolution ◽

Log P ◽

Physical Parameters ◽

Direct Compression ◽

Formulation Development ◽

Compression Technique

Formulation development is an important part of drug design and development. Bioavailability and bioequivalence are totally dependent on formulation development. Now-a-days formulation development is done by following QbD (Quality by Design).The aim of present study is to formulate Gemfibrozil (Gem) sustained release (SR) and immediate release (IR) bilayer tablet by different concentration of Hydroxypropyl methylcellulose (HPMC) and HPMC K 100 M to control the release pattern. The sustained release layer of Gem was prepared by using different grades of HPMC like, HPMC K-15, HPMC K-4 along with other excipients by direct compression technique. The immediate release layer of Gem was prepared by Cross carmellose sodium, Crospovidone and Sodium starch glycolate by direct compression technique. The powders were evaluated for their flow properties and the finished tablets were evaluated for their physical parameters. The both immediate release and sustained release layers of Gem were characterized by FT-IR and in vitro dissolution studies. The drug release study of Gem was evaluated using USP-II paddle type dissolution apparatus. The release rate of Gem in immediate release layer was studied for 15 min in 0.1 N HCL media and that of Gem in sustained release layer was studied for 12 h in 0.1 N HCL. From the nine batches F6 batch showed good release behaviour 99.85% of drug is released over 12 hours. Gem belongs to BCS Class II (log P 3.6) with poor solubility and high permeability resulting in limited and variable bioavailability. Total four trial batches of each drug have been manufactured to optimize and develop a robust and stable formulation, the stability studies of the products also comply with ICH guideline. Keywords: Bilayer floating tablets, Gemfibrozil, Biphasic drug release, HPMC K 15.

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Optimized chronomodulated dual release bilayer tablets of fexofenadine and montelukast: quality by design, development, and in vitro evaluation

Future Journal of Pharmaceutical Sciences ◽

10.1186/s43094-019-0006-9 ◽

2019 ◽

Vol 5 (1) ◽

Cited By ~ 1

Author(s):

Bhupendra Singh ◽

Geetanjali Saini ◽

Manish Vyas ◽

Surajpal Verma ◽

Sourav Thakur

Keyword(s):

Drug Release ◽

Sustained Release ◽

Quality By Design ◽

Immediate Release ◽

Oral Dosage ◽

Nocturnal Asthma ◽

Sustained Release Tablet ◽

Bilayer Tablets ◽

Dual Release ◽

Release Tablet

Abstract Background The conventional oral dosage forms are not effective in dealing with chronopathological conditions, such as nocturnal asthma. Therefore, there is an unmet need to develop a delivery system that can deliver drug as per the chronopharmacology of the diseases. The purpose of the study is to use quality by design (QbD) technique and pulsatile principles for the development of Eudragit-coated dual release bilayer tablets. The dual layer consists of immediate release layer of fexofenadine HCl and sustained release layer of montelukast sodium. Results The quality target product profile of the formulation was developed, and the critical quality attributes were identified. Three-level, three-factor Box-Behnken design was used for the optimization of the bilayer tablets. Based on the design, a total of 13 formulation combinations (F1–F13 and M1–M13) were made having acceptable micromeritic properties. The developed immediate and sustained release layers were evaluated for physicochemical properties. Depending upon the value of the diffusion exponent, the Fickian diffusion mechanism is dominant among immediate and sustained release tablet layers. Response curve for immediate release layer showed that concentrations of sodium starch glycolate and sodium bicarbonate had a negative effect on disintegration time and a positive effect on drug release. For sustained release tablet layer, concentrations of HPMC E 5 LV and magnesium stearate had a significant effect on drug release. The ANOVA and diagnostic plots confirmed the significance and goodness of fit of the used model. Based on desirability plot values, optimized formulation was developed and coated with Eudragit coat. The coated bilayer tablet showed met the requirement of providing an immediate release during the first hour and a sustained release action for a period of more than 8 h after passing the gastric region. Conclusions The formulation can be fruitful in curbing the menace of nocturnal asthma and providing a high degree of patient compliance as the patient will not have to wake up at night to take the medication.

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