FORMULATION AND EVALUATION OF THYROID HORMONE(T3) IMMEDIATE RELEASE TABLETS

Author(s):  
Farghana Begam ◽  
Rajalakshmi A. N ◽  
Padmapriya S

The study was aimed to formulate and evaluate Thyroid hormone (T3) immediate release tablets of a model Reference Listed Drug (RLD). The objective was to develop a cost effective immediate release tablet formulation and to optimize the formula in product development same that of the reference product. The ingredients used were API (thyroid hormone), lactose monohydrate (diluent), acacia (binder), maize starch (disintegrant), sodium chloride (alkalinizing agent) and magnesium stearate (lubricant). The concentration of maize starch and magnesium stearate were altered to reach the objective. Totally five formulations (F1 - F5) were prepared by direct compression method. The plan of work involved involved in the study was1 Selection of drug and excipients, 2Physico–chemical characterization and drug identification, 3Preformulation parameters of the drug, 4Pre–compression parameters for the tablet blend, 5Formulation and development of the tablet dosage form, 6Post compression parameters of the tablet and 7Stability study. The stability studies were performed as per ICH guidelines. Among all the formulations F5 was found to be the best as it showed better results than the other formulations. In vitro disintegration time and percentage drug release results shown satisfactory results. Stability study results showed no significant changes in the formulation. Keywords: Thyroid hormone (T3), Immediate release tablets, Direct compression, Dissolution.

Author(s):  
Madhivardhana P ◽  
Rajalakshmi A N ◽  
Padmapriya S

The aim of this research work is to formulate and evaluate Levothroxine sodium immediate release tablets prepared by direct compression method . Five formulations were evaluated for different pre and post compression parameter and in vitro drug release studies.The results of pre compression parameters of formluation 1 to 5 were compared with prescribed limits. It showed that formulation 1 to 5 powder blend exhibit good flow property and compressibility property. The disintegration time of all formulation was found to be in the range 2mins 09 secsto 4mins 03 secs.Thus, based on evaluation of different parameters it was concluded that formulation of immediate release tablet Levothyroxine sodium was successfully done and F-5 showed almost 93% drug release at 45 mins in Alkaline borate buffer( pH 10). Keywords: Thyroid hormone (T4), Immediate release tablets, Direct compression, Dissolution.


2017 ◽  
Vol 9 (4) ◽  
pp. 92
Author(s):  
Hrishav Das Purkayastha ◽  
Bipul Nath

Objective: The aim of the present investigation was to design and evaluate orally disintegrating tablet (ODT) of Ibuprofen, a NSAID drug used for the treatment of arthritis with a view to improve its oral bioavailability. The focus of the current study was to develop ODT of Ibuprofen using super disintegrants for ease of administration and its physicochemical characterization.Methods: Tablets were made from blends by direct compression method. All the ingredients were passed through mesh no. 80. All the ingredients were co-ground in a pestle motor. The resulting blend was lubricated with magnesium stearate and compressed into tablets using the Cadmach single punch (round shaped, 8 mm thick) machine.Results: Physicals parameters of the prepared tablets like Hardness, Weight variation, Friability, thickness, drug content etc. found within the limits. The disintegration time of prepared ODTs was in the range of 45 to 55 seconds. In vitro dispersion time was found to be 22 to 52 seconds which may be attributed to faster uptake of water due to the porous structure formed by super disintegrants. Short disintegration and faster release of ibuprofen were observed with Cross carmellose sodium as compared to sodium starch glycollate.Conclusion: It is concluded that F3 offered the relatively rapid release of Ibuprofen when compared with other formulations. The increase in the concentrations of super disintegrants may lead to increase in the drug release. The formulation prepared with cross carmellose sodium was offered the relatively rapid release of Ibuprofen when compared with other concentrations of both the super disintegrant. 


2019 ◽  
Vol 9 (1-s) ◽  
pp. 229-239
Author(s):  
J Nandhini ◽  
AN Rajalakshmi

The objective of this study was to enhance the solubility of Methylprednisolone by choosing micronized form of drug and to enhance patient compliance by formulating it as dispersible tablets using quality by design (QbD) approach. Dispersible tablets of Methylprednisolone were developed by 23 factorial design. In this study independent variables were concentrations of MCC 102, CCS and Magnesium stearate and dependent variables were disintegration time, hardness and dissolution. The resulting data was fitted into Design Expert Software (Trial Version) and analyzed statistically using analysis of variance (ANOVA). The response surface plots were generated to determine the influence of concentration of MCC 102, CCS and magnesium stearate on responses. The tablets were prepared by direct compression method by choosing micronized form of drug and formulations were evaluated for the standard of dispersible tablets. Results showed that no significant drug-polymer interactions in FTIR studies. According to QbD suggestion the formulation O1 (Desirability- 0.73) with MCC-38mg, CCS-3.5mg and magnesium stearate-2.5mg was formulated and evaluated. The disintegration time was found to be 69 seconds, hardness was found to be 64N and in vitro dissolution with in 30minutes. Optimized O1 formulation was within the limits of standards of dispersible tablets with increased water solubility and better patient compliance. Stability study on optimized O1 formulation showed that there is no significant changes during study period. Thus, O1 formulation was found to be stable. The study indicates that formulation of Methylprednisolone dispersible tablets by using QbD approach is a promising formulation development method. Keywords: Dispersible tablets, Methylprednisolone, Direct compression, Quality by Design and ANOVA.


2013 ◽  
Vol 1 (02) ◽  
pp. 01-08
Author(s):  
B. Brahmaiah ◽  
K. Sasikanth ◽  
Sreekanth Nama ◽  
P. Suresh ◽  
Patan Adam Khan

In the present study, design of oral immediate release tablets of Valsartan by direct compression technique was carried out. The main aim and objective of the work is to formulate immediate release tablets using different direct compression vehicles (DCV’S) in different ratios. The main motive is to compare the dissolution profile of these formulations and conclude the best formulation which release drug at a faster rate. To determine the best fit dissolution profile for the dosage forms. Valsartan tablets were formulated by using microcrystalline cellulose (diluents), potato starch, acacia (binder) and magnesium stearate (lubricant). The granules were compressed into tablets and were subjected to dissolution studies. The dissolution profile of the formulation F2 was found to have better dissolution rate compared to others. The In-vitro dissolution studies of all the formulations were conducted and the results were obtained, it was concluded that formulation F2 was the best with fast release of drug compared to others.


2012 ◽  
Vol 2 (1) ◽  
pp. 7
Author(s):  
Ahmed Abd Elbary ◽  
Howida K. Ibrahim ◽  
Balquees S. Hazaa

Simvastatin is a well established oral antihypercholesterolemic agent. This study aimed to formulate simvastatin as orodispersible tablets. The drug was incorporated as a solid dispersion using Pluronic® F68 as carrier. Croscarmellose Na was used as superdisintegrant, microcrystalline cellulose as filler, PVP K-30 as binder and 1:1 magnesium stearate/talc mixture as lubricant. Box- Behnken design was adapted to explore the main and interaction effects of three independent formulation variables on the prepared tablets, namely superdisintegrant concentration (X1), lubricant mixture concentration (X2), and binder concentration (X3). A total of 13 tablet formulations were fabricated in addition, to two replicates of the center point to assess variability and experimental error. The selected dependant variables were the<em> in vitro</em> and <em>in vivo</em> disintegration times, dissolution rate at 4 min, and dissolution efficiency after 30 min. Wetting time, drug content, hardness and friability were also evaluated. Tablet formula, composing of 12% superdisintegrant, 2% lubricant mixture and 3% binder, showed the highest dissolution rate with an acceptable disintegration time (43 sec), hardness, and friability and was chosen as the best formula. An accelerated stability study was conducted for 6 months at 40°C/75% RH. Results showed no significant changes in any of the tested parameters.


INDIAN DRUGS ◽  
2018 ◽  
Vol 55 (12) ◽  
pp. 34-40
Author(s):  
V.V Pande ◽  
◽  
A.A. Patel ◽  
V.P. Patel ◽  
P.V. Khedkar

The mouth dissolving film overcomes the shortfalls of conventional quick dispersing/dissolving intraoral tablets. Fosinopril is an angiotensin converting enzyme (ACE) inhibitor used for the treatment of hypertension and some types of chronic heart failure.It undergoes extensive hepatic first pass metabolism, with bioavailability being only 36%. In the present investigation, an attempt was made to formulate fast dissolving film of fosinopril sodium by Solvent casting method using various film forming polymers such as HPMC 5cps, HPMC E-3, HPMC E-15 each being varied at three different concentration(6%,8%,10%). Drug-excipient compatibility studies were carried out by FTIR spectroscopy and DSC. in order to establish compatibility between drug and excipients The results revealed that the drug and excipients were satisfactorily compatible, without any significant changes in the chemical nature of the drug. Prepared films were subjected to different evaluation parameters such as folding endurance, physical appearance, %moisture absorption,drug content uniformity, in vitro disintegration time, in vitro dissolution studies and stability studies. All the formulations show name accurred compliance with pharmacopoeial standards. The stability study shows that no significant changes in films after one month study. Results revealed that the formulations F1 containing 6% HPMC 5cps showed better release property, low disintegration time, good folding endurance and good physical appearance compared to other formulations, so it was selected as the best formulation.


2020 ◽  
Vol 10 (3-s) ◽  
pp. 17-25
Author(s):  
Inder Kumar ◽  
Dipima Chaudhary ◽  
Bhumika Thakur ◽  
Vinay Pandit

Objective: In the present research work, fast dissolving tablets of Piroxicam were formulated by two different techniques i.e. direct compression method and sublimation method using different superdisintegrants. Methods: Twelve formulations were prepared (PXM1 to PXM12) in which first six formulation were prepared by direct compression technique and other six formulation were prepared by sublimation method by using camphor as a sublimating agent. Result and Discussion: All the formulations were subjected for precompression, post compression parameters, and shows all the data within the specific limits. Formulation PXM4 containing 5 % crospovidone showed 99.480 ± 0.291 % drug release in 20 min which was more than the drug release of rest of the formulations. The optimized formulation PXM4 was compared with the marketed formulation and it revealed that drug release of PXM4 was found to be 99.397 ± 0.751 % in 20 min, which was greater than the marketed formulation. Finally, results were statistically analysed by the application of one way ANOVA and t-test. The stability study of the optimized formulation PXM4 showed no significant changes in, drug content, disintegration time and in-vitro drug release. Conclusion: Piroxicam can be successfully prepared using direct compression technique and it will enhance the drug dissolution, which will further increase absorption and bioavailability of the drug. Keywords: Direct compression, fast dissolving tablets, sublimation, Piroxicam.


Author(s):  
Rai V. K. ◽  
Pathak N. ◽  
Bhaskar R. ◽  
Nandi B. C. ◽  
Dey S. ◽  
...  

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.


Author(s):  
Sonali Agarkar

To effectively manage the diabetic mellitus type-II hyperglycemic problem, Gliclazide tablet is the sustained- release tablet that has been designed and fabricated for years. This research evaluated the effects of different grades of hydrophilic polymers in sustained release of Gliclazide tablets made with direct compression technique. HPC GF GRADE, HPMC K4M, and PARTECK® SRP 80 were used as the polymer, Avicel pH 101 (MCC) was used as the highly compressible diluent and Starch 1500 was used as insoluble tablet filler. Aerosil 300 and Magnesium Stearate was used as a Glidant and lubricant for improving the flow property of powder and to decrease the friction between dying wall and punches. Pre-compression characteristics were evaluated for angle of repose, bulk density, compressibility, tapped density, and Hausner's ratio and DSC, XRD, FT-IR. Tablets were prepared on a rotary tablet press machine (Eliza press) and after compression tablets were evaluated for weight variation, thickness, hardness, friability, drug content, and in-vitro drug release study. The physico-chemical properties of blends were estimated accelerated stability study was also developed formulations were kept for stability study for three months as per ICH guidelines and found to be stable. Advantages of formulating insoluble drugs such as Gliclazide is that if it is used in the preparation of capsules or tablets of the drug,its dose might be reduced which is economically beneficial.


Author(s):  
SHALLY SHARMA ◽  
NIMRATA SETH ◽  
NARESH SINGH GILL

Objective: The present study aims to formulate and evaluate Fast dissolving tablet of Buspirone, the drug that is used for management of anxiety, by direct compression method using various Super disintegrants. Methods: Ten formulations (F1-F10) of fast dissolving tablets of Buspirone were prepared by using various Superdisintegrants. The prepared tablets were evaluated for hardness, friability, thickness, drug content uniformity, water absorption, wetting time, and disintegration time and in vitro dissolution study. Results: Among all the formulations, F10 (containing 5 mg of Coprocessed (CS: SSG 1:2) Superdisintegrants) was considered to be the best formulation, which released up to 98% drug in 20 min as compared to a marketed conventional dosage form which dissolves in approx 60 min. The results of stability study of formulation F10 after a period of two months indicated that the formulation was stable. Conclusion: It was concluded that a fast-dissolving tablet of Buspirone containing various Superdisintegrants is better and effective to meet patient compliance.


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