scholarly journals FORMULATION, DEVELOPMENT AND EVALUATION OF IMMEDIATE RELEASE ROSUVASTATIN CALCIUM TABLET

2021 ◽  
Vol 11 (6) ◽  
pp. 25-30
Author(s):  
Prashant L. Pingale
Keyword(s):  
Research Work ◽  
Flow Characteristics ◽  
Cost Effective ◽  
Immediate Release ◽  
Wet Granulation ◽  
Formulation Development ◽  
Release Formulation ◽  
Disintegration Time ◽  
Rosuvastatin Calcium

Rosuvastatin belongs to the statin medication class, which is used to treat excessive cholesterol and prevent heart disease. The Biopharmaceutical Classification System classifies it as class II. The goal of this project is to create 10 mg Rosuvastatin instant release pills using several types of materials. To boost the drug's bioavailability, superdisintegrants were used to speed up the disintegration and dissolution of Rosuvastatin calcium. Cited research work aims to formulate an immediate release tablet of Rosuvastatin for the treatment of hypercholesterolemia, hypolipoproteinemia, and atherosclerosis. The present work used a cost-effective wet granulation process to create an immediate release formulation of Rosuvastatin calcium. All of the batches were manufactured, and the granules were evaluated for pre-compression properties such as loss on drying, bulk density, tapped density, and compressibility index. Disintegration time and assay were determined to be within acceptable parameters, as were weight fluctuation, thickness, hardness, and friability of tablets. The effect of several superdisintegrants on in vitro dissolutions in 6.8 PH phosphate buffer was investigated. The final formulation was chosen based on the dissolving profile; dissolution studies revealed that formulations F2 and F4 released 80 percent of the medication within 15 minutes. Two different formulations of Rosuvastatin Calcium 5.199 and 10.398 mg employing immediate-release tablets were successfully generated using Crospovidone, Meglumine, and Comprecel 112D+®. The tablets showed complete drug release in 60 minutes and fair flow characteristics when compared to the innovators' product.

Formulation and Evaluation of Immediate Release Bilayer Tablets of Telmisartan and Hydrochlorothiazide

2011 ◽  
Vol 4 (3) ◽  
pp. 1477-1483
Author(s):  
Natarajan R ◽  
N Patel ◽  
Rajendran N N ◽  
M Rangapriya
Keyword(s):  
Antihypertensive Drugs ◽  
In Vitro Release ◽  
Immediate Release ◽  
Wet Granulation ◽  
Physical Parameters ◽  
Dissolution Profile ◽  
Formulation Development ◽  
Sodium Starch Glycolate ◽  
Bilayer Tablets

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.  

scholarly journals Formulation, Characterisation and Evaluation of the Ethosuximide Oral Immediate Release Tablets

2020 ◽  
Vol 11 (2) ◽  
pp. 1807-1813
Author(s):  
Naga Sujan M ◽  
Kunal K Mehta ◽  
Amit B Patil ◽  
Anusha Vajhala
Keyword(s):  
Drug Release ◽  
Dosage Form ◽  
Immediate Release ◽  
Rice Starch ◽  
Wet Granulation ◽  
Drug Release Profile ◽  
Disintegration Time ◽  
In Vitro Drug Release ◽  
Release Studies

The present study is aimed to formulate, characterization, and evaluate oral immediate-release tablets of Ethosuximide. It is employed as an anti-epileptic agent used in the treatment of epilepsy, in all the age groups who were≥ 1 year. The dosage form is formulated by directly compressing the blend and granulating the powder blend by wet granulation methods. The optimized formulation is achieved by the trial and error method by changing the concentration of lactose monohydrate and di-basic calcium phosphate dehydrate as diluents, sodium starch glycolate as Super-dis-integrant, rice Starch as an intra-granular binder, hydroxypropyl cellulose as binder talc as a lubricant. Evaluation parameters such as micrometric properties, disintegration time along with in-vitro drug release studies were performed for characterizing the dosage form. In-vitro drug release studies were carried out using 0.1 N HCl as dissolution media with 75 rpm and temperature of 370C ± 50C by employing USP apparatus II (Paddle type). Estimation of the % drug release of the tablet was carried out using the UV method. The prepared formulation and the marketed formulation were tested for the in-vitro drug release profile and the prepared formulation was compared with the marketed formulation. All the evaluated result was found to be within the specifications. Therefore, from the obtained evaluation results F6 trail was selected as the best formulation.

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

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

scholarly journals SOLUBILITY ENHANCEMENT OF GLIBENCLAMIDE USING MESOPOROUS SILICA

2019 ◽  
pp. 302-314
Author(s):  
Swati Mittal ◽  
AKSHAY SONAWANE ◽  
MANGESH KHUNE
Keyword(s):  
Drug Release ◽  
Mesoporous Silica ◽  
Drug Loading ◽  
Immediate Release ◽  
Formulation Development ◽  
Scanning Calorimetry ◽  
Disintegration Time ◽  
Drug Precipitation ◽  
Poorly Soluble

Glibenclamide is a BCS Class II drug and poses a major problem during formulation development. In the present study, adsorption onto various carriers was used to enhance the solubility of glibenclamide. It was observed that solubility of glibenclamide was greatly enhanced by adsorbing onto mesoporous silica. The increase in solubility of poorly soluble drugs is often associated with the generation of supersaturation, which results in the risk of drug precipitation. HPMC E5 was used as precipitation inhibitor to maintain sink condition for a longer duration. A 32 full factorial design was adopted to optimize the ratio of glibenclamide (X1) and mesoporous silica as a carrier (X2) and the effect of different ratios was studied on percent yield, percent drug loading, and percent drug release. X-ray powder diffraction (XRPD) and Differential scanning calorimetry studies were performed to investigate any possible interaction in between glibenclamide and mesoporous silica. An optimum batch of drug adsorbate was used to prepare immediate-release tablets. The tablets prepared were evaluated for thickness, uniformity of weight, hardness, friability, in-vitro disintegration time, and in vitro drug release study.

scholarly journals Formulation Development and in vitro Evaluation of Eletriptan Fast Dissolving Oral Films

2018 ◽  
Vol 10 (6) ◽  
Author(s):  
Shrushti V. Somwanshi ◽  
Sanjay S. Thonte
Keyword(s):  
Research Work ◽  
Morphological Properties ◽  
In Vitro Dissolution ◽  
Content Uniformity ◽  
Reference Standard ◽  
Formulation Development ◽  
Disintegration Time ◽  
Significant Difference ◽  
Oral Films

The present study aimed at preparing fast dissolving oral films of Eletriptan as a model drug which is used for the migraine treatment. Fast dissolving dosage forms have acquired great importance in pharmaceutical industry because of their unique properties. In the present research work various trials were carried out using different grades of HPMC E3, E6, and E15, maltodextrin DE6 and other polymers by solvent casting method. The prepared films were evaluated for film thickness, folding endurance, surface pH, morphological properties, % drug content and content uniformity, tensile strength, percent elongation, in vitro disintegration time and in vitro dissolution studies. The optimized formulation F24 prepared using HPMC E15 showed minimum disintegration time (10 sec), highest dissolution rate i.e. 99% of drug within 8 min and satisfactory physicochemical properties. The optimized film was evaluated for its bioavailability compared with pure drug as reference standard. Statistical analysis revealed that no significant difference between the bioavailability parameters of the film and the reference standard indicated that they exhibited comparable plasma level-time profiles. These findings suggest that the fast dissolving film containing Eletriptan is considered to be potentially useful for the treatment of migraine where quick onset of action is desirable.

scholarly journals Formulation development and evaluation of duloxetine extended-release tablets

2021 ◽  
pp. 62-67
Author(s):  
Saibabu Ch ◽  
Naresh M ◽  
Sirisha K ◽  
Vineetha R ◽  
Sai Kumar P ◽  
...  
Keyword(s):  
Extended Release ◽  
Immediate Release ◽  
Wet Granulation ◽  
Dissolution Profile ◽  
Formulation Development ◽  
Compression Process ◽  
In Vitro Drug Release ◽  
Profile Matching ◽  
Core Tablet

Duloxetine  is an anti-depressant drug which is used in depression. The aim of present investigation was to prepare an ER tablet of duloxetine with similar dissolution profile matching to Effexor ER. An immediate release core tablet of 100mg was prepared and it was compression coated using HPMC matrix system. HPMC of three viscosity grades i.e., K4M, K15M, K100M and different concentrations of 15% polymer, 25% polymer, 35% polymer & 45% polymer were taken. With the above polymers by using wet granulation and direct compression process 11 formulations were prepared. The data obtained from in vitro drug release was used to determine the similarity factor between marketed and optimized product. Out of all F11 formulation (K15M 35% polymer) is optimized and is matching with the marketed product.

Formulation Development and Characterization on the Impact of Superdisintegrants on Oral Dispersible Tablets of Didanosine

1970 ◽  
Vol 9 (2) ◽  
pp. 3181-3188
Author(s):  
Suryakanta Swain ◽  
Muddana Eswara Bhanoji Rao ◽  
Chinam Niranjan Patra ◽  
Sitty Manohar Babu
Keyword(s):  
Dissolution Rate ◽  
Immediate Release ◽  
Conventional Technique ◽  
Formulation Development ◽  
Disintegration Time ◽  
Ich Guidelines ◽  
Dispersible Tablet ◽  
Mouth Feel ◽  
The Impact

The present study was undertaken to develop and evaluate an oro-dispersible tablet of didanosine by direct compression using cross carmellose sodium, crosspovidone and sodium starch glycolate (5-20%) as a superdisintegrants, Avicel 102 (15-30%) was used as diluents along with directly compressible mannitol  (20%) to enhance mouth feel, faster disintegration and dissolution rate of the drug. Absorption of the drug can be impacted by oral fast dissolving dosage form; this may have implication for medications to treat human immunodeficiency virus (HIV) infection and those having difficulty in swallowing tablets or capsules resulting in improved patient compliance. The prepared tablets were evaluated for impact of superdisintegrants on the disintegration behavior of the tablet in the oral cavity and also evaluated for post compression parameters and         in vitro drug release characteristics. The tablets demonstrated a hardness of 3 to 6 kg/cm2, friability of 0.48 to 1 %, disintegration time of 5 to 14 sec and drug content was found to be 98 to 100 %. Based on evaluation parameters the formulation (F6) containing 20 % of crosspovidone and 15% of MCC Avicel 102 showed promising performance against all other formulations with hardness of 5 ± 0.13 kg/cm2 and faster disintegration within 5 s and better dissolution rate. An appropriate combination of excipients made it possible to obtain orally disintegrating immediate release tablets of didanosine using simple and conventional technique. The formulations were subjected to stability studies as per ICH guidelines and were found to be stable after a 3 months study.

scholarly journals Preparation and Evaluation of Natural Gum-Based Immediate Release Metformin Hydrochloride Tablet

2018 ◽  
Vol 21 (2) ◽  
pp. 101-108
Author(s):  
Sreebash Chandra Bhowmik ◽  
Marzia Alam ◽  
Md Saiful Islam Pathan
Keyword(s):  
Immediate Release ◽  
Angle Of Repose ◽  
Metformin Hydrochloride ◽  
Wet Granulation ◽  
Class Iii ◽  
Aegle Marmelos ◽  
Disintegration Time ◽  
Weight Variation ◽  
Natural Gum

Metformin hydrochloride is a first line BCS class III oral anti-diabetic drug used for the treatment of type 2 diabetes. The main goal of this study was to formulate, prepare and evaluate natural gum-based immediate release metformin hydrochloride tablet. Seven different formulations of compressed tablets were prepared following wet granulation process using different concentrations (10, 20, 30, 50, 60, 70, 80 and 90 mg) of Aegle marmelos gum as a binder. Aegle marmelos gum is a biodegradable natural gum which is economic, easily available and found useful as tablet binder for both conventional and novel dosage forms. Other excipients used in the formulation were microcrystalline cellulose (MCC), croscarmellose sodium (CCS), maize starch, colloidal silicon dioxide (CSD), sodium starch glycolate (SSG), magnesium stearate etc. In the present study, the compressed tablets were evaluated for weight variation, thickness, hardness, friability, disintegration time and dissolution. In vitro drug release study was carried out in phosphate buffer (pH 6.8) at 37 ± 0.5oC with 50 rpm using USP Dissolution Apparatus 2-Paddle method. The flowability of granules for all the batches was optimum which reflected in the bulk density and angle of repose. It can be concluded from this study that combination of Aegle marmelos as a binder with other excipients can be prospectively used in the preparation of metformin hydrochloride immediate release (IR) tablet.Bangladesh Pharmaceutical Journal 21(2): 101-108, 2018

scholarly journals Design, Development, and Characterization of Amorphous Rosuvastatin Calcium Tablets

2021 ◽  
Author(s):  
Rocío González ◽  
Mª Ángeles Peña ◽  
Norma Sofía Torres ◽  
Guillermo Torrado
Keyword(s):  
Dissolution Rate ◽  
Active Ingredient ◽  
Cost Effective ◽  
Direct Compression ◽  
Dissolution Profile ◽  
Design Development ◽  
Scanning Calorimetry ◽  
Disintegration Time ◽  
Rosuvastatin Calcium

This work proposes a methodology for the design, development, optimisation, and evaluation of amorphous rosuvastatin calcium tablets (BCS class II drug). The main goal was to ensure rapid disintegration and high dissolution rate of the active ingredient, thus enhancing its bioavailability. The design started from a careful selection of excipients, which due to their characteristics and proportions within the formulation allowed the use of their properties such as fluidity or granulometric distribution. The formulation was characterised using scanning electron microscopy (SEM), differential scanning calorimetry (DSC), thermogravimetry (TGA), Fourier transform infrared spectroscopy (FT-IR) and powder X-ray diffraction (PXRD) methods. The galenic SeDeM methodology was used to establish the profile of the active ingredient-excipient mixture and guarantee its suitability for producing tablets by the direct compression method. The results demonstrate that the amorphous rosuvastatin calcium tablets formulation developed made it possible to obtain cost-effective tablets by direct compression with optimal pharmacotechnical characteristics that showed a remarkable disintegration and dissolution rate. The manufactured tablets complied with the pharmacopoeia guidelines regarding uniformity of weight, tablet hardness, thickness, friability, in vitro disintegration time and dissolution profile.

scholarly journals Optimization of Immediate Release Tablet of Raloxifene Hydrochloride by Wet Granulation Method

2009 ◽  
Vol 1 (01) ◽  
Author(s):  
Rai V. K. ◽  
Pathak N. ◽  
Bhaskar R. ◽  
Nandi B. C. ◽  
Dey S. ◽  
...  
Keyword(s):  
In Vitro Release ◽  
Immediate Release ◽  
Magnesium Stearate ◽  
Wet Granulation ◽  
Disintegration Time ◽  
Weight Variation ◽  
Raloxifene Hydrochloride ◽  
Vitro Release ◽  
Release Tablet

The purpose of this research is to prepare Raloxifene Hydrochloride immediate release tablet by wet granulation technique. In order to obtain the best, optimized product six different formulations were developed. Different filler, binder, disintegrant and lubricant were taken as variables. Weight variation, thickness, hardness, friability, disintegration time, in-vitro release and pharmaceutical assay were studied as response variables. Sticking was observed when the formulation containing stearic acid and sodium stearyl fumarate. However, in the remaining four formulation containing magnesium stearate, no sticking was observed. The formulation NP061 was selected as an optimized product. The different physical properties and in-vitro release profile showed best comparable with reference product. Optimization has proven as an effective tool in product development.

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