scholarly journals Formulation and evaluation of orally disintegrating tablet containing taste masked mirtazapine

2021 ◽  
Vol 10 (2) ◽  
pp. 71-80
Author(s):  
Shrestha Prabhat ◽  
Shrestha Rajan ◽  
Shrestha Sahana
Keyword(s):  
Research Work ◽  
Cost Effective ◽  
Threshold Value ◽  
Taste Masking ◽  
Polymer Complex ◽  
Disintegration Time ◽  
Orally Disintegrating Tablet ◽  
Dispersible Tablet ◽  
Wetting Time ◽  
Eudragit Epo

Objective: This study aims to prepare the taste-masked granules of Mirtazapine by mass extrusion technique and formulate it into an oral dispersible tablet using different super disintegrates. Methods: Taste masked granules of mirtazapine were prepared by mass extrusion technique using Eudragit EPO in different ratios. The drug-polymer ratio was optimized based on the percent drug release in SSF and SGF. Taste masking efficacy of drug-polymer complex was determined by developing the bitterness threshold value of Mirtazapine. The selected drug-polymer complex was formulated into an oro-dispersible tablet by direct compression method. A randomized design was used to investigate individual effect of three different super disintegrates each in different concentrations. Ten formulations were developed including a controlled formulation without the addition of superdisintegrants. A comparative study was done based on various pre-compression and post-compression parameters. Results: Eudragit EPO was able to mask the bitter taste of Mirtazapine effectively in 1:2 ratio by mass extrusion method. The minimum disintegration time and wetting time was found to be 13.6±2.7 and 18.13±0.24 seconds with the formulation containing crospovidone 5% (F9). It was found that the wetting time and disintegration time followed the order SSG>CCS>CPV. The selected best formulation was subjected to an incompatibility study design. The IR spectrum showed that all the excipients were chemically compatible. Conclusion: Thus, in this study unpalatable taste of Mirtazapine was masked using Eudragit EPO polymer by mass extrusion technique, and superdisintegrants were added to prepare orally disintegrating tablets of Mirtazapine. This research work suggests a rapid, simple and cost effective method for formulating Mirtazapine ODT.

scholarly journals EFFECT OF PLANTAGO OVATA MUCILAGE USED AS NATURAL SUPERDISINTEGRANT ON RAPIMELTS TABLET OF METACLOPRAMIDE HCL

2019 ◽  
Vol 8 (4) ◽  
Author(s):  
Abhinav kumar Tripathi ◽  
Hemendra Gautam
Keyword(s):  
Taste Masking ◽  
Polymer Complex ◽  
Stability Studies ◽  
Formulation Development ◽  
Compression Method ◽  
Plantago Ovata ◽  
Disintegration Time ◽  
Ich Guidelines ◽  
Key Variables ◽  
Wetting Time

Formulation, development and optimization of rapimelts containing metoclopramide HCl using natural superdisintegrant To isolate mucilage from the plantago ovata husk powder by pregelatinization method. To prepare priliminary trial batches of repimelts using β cyclodextrin with different ratio of drug and polymer. To evaluate the drug polymer complex and finally which polymer and ratio of drug and polymer is better to formulate final formulation. To achieve taste masking of drug. To prepare preliminary trial batches of rapimelts using plantago ovata mucilage as natural superdisintegrant and crosspovidone as synthetic superdisintegrant by direct compression method. To evaluate the prepared rapimelts for various properties like friability, hardness, wetting time, water absorption ratio, disintegration time, drug content, drug  etc. Identifying the key variables and their levels for applying factorial design and to optimize one formulation. To evaluate the final batches and find out the optimized batch based on statistical optimization using experimental design. To compare the optimized formulation with marketed preparation. To carry out stability studies of optimized batch as per ICH guidelines. The aim of the present investigation was to Formulate, designed, and evaluates plant agoovata mucilage used as a natural superdisintegrant was to developed and optimized rapimelts containing Metoclopramide HCL. Keywords: Rapimelt , Superdisintegrant, Rapimelt Super disintegrate, Metaclopramide hydrochloride

Formulation and Evaluation of Baclofen Orally Disintegrating Tablets

1970 ◽  
Vol 2 (4) ◽  
pp. 733-738
Author(s):  
Dumpeti Janardhan ◽  
Joginapally Sreekanth ◽  
P.Theja Pavan Kumar ◽  
M.Vamshi Krishna
Keyword(s):  
Pilot Scale ◽  
Taste Masking ◽  
Wet Granulation ◽  
Physical Parameters ◽  
Disintegration Time ◽  
Granulation Process ◽  
Good Taste ◽  
Orally Disintegrating Tablets ◽  
Human Volunteers ◽  
Eudragit Epo

The purpose of this study was to evaluate the potential of polymers for masking the taste of bitter drugs when incorporated into orally disintegrating tablets. The tablets were produced by simple wet granulation technique with a model compound (baclofen) which is moderately bitter. The formulating procedure had two variables to obtain good taste masking with desirable characteristics. The optimal granulation process parameters were polymer selection and its concentration (w/w), suitable for pilot scale level. Dextrates, β- cyclodextrin, eudragit EPO and PVP K-30 were used in preparation of granules by using water and iso-propyl alcohol. Crospovidone was used intra and extra granularly as superdisintegrant.  Sodium bicarbonate and citric acid were used as effervescent for fast disintegration of tablets, which also optionally act as desensitizer of taste buds. Results from evaluation of tablets indicated a disintegration time (avg) of 30-35 sec and 100% drug release was achieved within 5 min. But taste masking was achieved by only with eudragit EPO. Results from an evaluation by a panel of six human volunteers demonstrated that the orally disintegrating tablets which are prepared by using polymer Eudragit EPO (5% and 7.5% w/w of tablet) and PVP (7.5% w/w of tablet) improved taste, significantly. On studying physical parameters, F9 formulation demonstrated acceptable level of hardness and friability with good taste masking and it was thus considered as an optimized formulation

Formulation and Evaluation of Orally Disintegrating Tablets of Lamotrigine

2015 ◽  
Vol 8 (2) ◽  
pp. 2881-2888
Author(s):  
Sudarshan Singh ◽  
S S Shyale ◽  
P Karade
Keyword(s):  
Drug Release ◽  
Water Soluble ◽  
In Vitro Dissolution ◽  
Disintegration Time ◽  
Orally Disintegrating Tablet ◽  
Drug Content ◽  
Weight Variation ◽  
Wetting Time ◽  
Croscarmellose Sodium

The aim of this study was to design orally disintegrating tablet (ODT) of Lamotrigine. It is an Antiepileptic drug which is widely used in epilepsy. It is also used in simple and complex partial seizures and secondary generalized tonic-clonic seizures. It is poorly water soluble drug (0.46 mg/ml). Thus, an attempt was made to enhance the water solubility by complexation with β-cyclodextrin (1:1 molar ratios). The orally disintegrating tablet of lamotrigine was prepared by direct compression method using different concentration of superdisintegrants such as Sodium starch glycollate, croscarmellose sodium by sublimating agent such as camphor. The formulations were evaluated for weight variation, hardness, friability, drug content, wetting time, in vitro disintegration time and in vitro dissolution studies. The prepared tablets were characterized by Fourier transform infrared spectroscopy and differential scanning calorimetry. The disintegration time for the complexed tablets prepared by different concentration of superdisintegrants was found to be in range of 32.54 ± 0.50 to 55.12 ± 0.57 sec and wetting time of the formulations was found to be in range of 28.47 ± 0.67 to 52.19 ± 0.72 sec. All the formulation showed almost 100 percent of drug release within 15 min. Among all the formulation F6 and F7 prepared with 18% croscarmellose sodium and camphor shows faster drug release, respectively 10 min, F6 gives good result for disintegration time, drug release, wetting time and friability. Further formulations were subjected to stability testing for 30 days at temperature of 40 ± 5 ºC/75 ± 5 %RH. Tablets showed no appreciable changes with respect to physical appearance, drug content, disintegration time and dissolution profiles. Results were statistically analyzed by one-way ANOVA at a p < 0.05. It was found that, the data at any point of time are significant at p < 0.05.

Development and Characterization of Orally Dissolving Tablet of a Poorly Soluble Antiemetic Drug

2021 ◽  
pp. 2172-2178
Author(s):  
Beena P ◽  
Arun G Krishnan ◽  
Nisha Ullas ◽  
Chippy S Pillai ◽  
Sam C Mathew ◽  
...  
Keyword(s):  
Cost Effective ◽  
Effective Dosage ◽  
Soluble Form ◽  
Antiemetic Drug ◽  
Disintegration Time ◽  
Dispersible Tablet ◽  
Poorly Soluble ◽  
Tablet Preparation ◽  
Compression Characteristics

The aim of present work is to prepare the orally dissolving tablets of poorly soluble Ondransetron Hydrochloride as its soluble form by adopting complexation method using different superdisintegrants alone and in combination. The growing importance of orally dissolving tablet was underlined recently when European Pharmacopoeia adopted the term “Oro dispersible tablet” as a tablet that to be placed in the mouth where it disperses rapidly before swallowing. Their characteristic advantages such as administration without water anywhere, anytime lead to their suitability to geriatric and paediatric patients. The complex prepared was showed better solubility in simulated salivary PH of 6.8. The pre compression characteristics of drug, drug with Beta cyclodextrin and final blend were evaluated with respect to standards. Results of the study showed that the optimized tablet with combination of superdisintegrants (2.5% crosspovidone, 3.5% sodium starch glycolate) showed hardness of 3.5Kg/Cm2, thickness 2.10mm, wetting time 18 sec, drug content 99.15%, disintegration time 20sec, in-vitro dispersion time 25sec, in-vitro drug release of 89.59% (in 3min) and percentage of drug permeation as 89.45% (in 5 min) and it is comparable with higher percentage of superdisintegrants used for tablet preparation. So this method was a promising approach for developing cost effective dosage form with high efficacy in treatment.

scholarly journals FORMULATION, IN VITRO, AND IN VIVO EVALUATION OF TASTE-MASKED ORAL DISINTEGRATING TABLETS OF FEXOFENADINE HYDROCHLORIDE USING SEMISYNTHETIC AND NATURAL SUPERDISINTEGRANTS

2021 ◽  
pp. 99-108
Author(s):  
NAGADANI SWARNALATHA ◽  
VIDYAVATHI MARAVAJHALA
Keyword(s):  
Desirability Function ◽  
Research Work ◽  
In Vivo Studies ◽  
Taste Masking ◽  
Wet Granulation ◽  
Maximum Plasma ◽  
In Vivo Evaluation ◽  
Eudragit Epo

Objective: The aim of the present research work was to prepare and evaluate taste-masked oral disintegrating tablets (ODT) of Fexofenadine hydrochloride. Methods: In the present work, Eudragit EPO, a taste masking agent and Karaya gum (GK) (natural), Sodium starch glycolate, and Croscarmellose sodium (CCS) (semi-synthetic) super disintegrants in three ratios (3, 6,9%) were used. Taste masked granules were prepared by different ratios of the drug: Eudragit EPO (1:1, 1:1.5, 1:2) by wet granulation method. The optimized taste-masked granules (1:2) were selected by sensory evaluation test to prepare 9 Fexofenadine ODT (FH1-FH9) formulations. These were evaluated for different parameters. Then desirability function (DF) was calculated for all formulations using disintegration time (DT), time taken for the tablet to release 90% of the drug (t 90%), and % drug dissolved in 10 min (Q10) as significant parameters. Results: The best formulation (FH6) showed the highest DF value due to less DT and 100% in vitro drug release within 15 min. Thus, FH6 formulation containing 9% CCS was selected as the best among the prepared formulations to which in vivo studies were performed on rabbits to find maximum plasma concentration (Cmax), time taken to reach maximum concentration (tmax), area under the curve (AUC), rate of elimination (Kel), absorption rate (Ka) and half-life(t1/2) and compared with Fexofenadine (Allegra) marketed tablets. Total bioavailability was increased for the test formulation compared to the reference formulation. Conclusion: Fexofenadine was successfully prepared as ODT with increased AUC and decreased tmax to which stability studies were conducted which were found to be stable.

scholarly journals Nifedipine Oral Disintegration Tablet: Design, Optimization, Invivo-pharmacokinetic and Stability Studies

2020 ◽  
Vol 11 (4) ◽  
pp. 8101-8107
Author(s):  
Arindam Chatterjee ◽  
Shaik Mohammad Abdulla ◽  
Nagarajan G ◽  
Birendra Shrivastava
Keyword(s):  
Optimization Design ◽  
Dosage Form ◽  
Excretion Rate ◽  
Cost Effective ◽  
Pharmacokinetic Studies ◽  
Disintegration Time ◽  
Elimination Half ◽  
Dispersible Tablet ◽  
Factorial Optimization ◽  
Bile Excretion

Nifedipine has a bioavailability of 45-56 percent and a 2-hour elimination half-life. It has a 50 percent kidney excretion rate and a 5-15 percent bile excretion rate. The intention of this research is to invent and evaluate Nifedipine loaded ODT and to prove the enhancement of bioavailability. The 23 factorial optimization design exposed about the outcome of independent variable on dependent variable throughout the formulation of Nifedipine ODT. From the records, it was accomplished that there was a good correlation between Disintegration time, Dissolution rate and super disintegration concentration. The formulation F4 (Nifedipine ODT) has achieve the goal of ODT drug delivery with desired release characteristics, cost-effective, decreased dose, effective administration and hence improved patient compliance. The invivo pharmacokinetic studies reveals that increase in AUC0-∞; decrease in Tmax; increase in Cmax in Nifedipine ODT shows better bioavailability and faster duration of therapeutic action than marketed Nifilat® dosage form. Nifedipine ODT was stable at various temperature, humidity conditions and there was no drastic change in evaluation parameters. That it was concluded that Oral dispersible tablet (ODT) was a suitable dosage form to enhance the solubility at the same time the bioavailability of BCS class II drugs like Nifedipine.

FORMULATION AND EVALUATION OF MOUTH DISSOLVING TABLETS OF RANITIDINE HYDROCHLORIDE

INDIAN DRUGS ◽  
2015 ◽  
Vol 52 (09) ◽  
pp. 13-20
Author(s):  
V Arora ◽  
◽  
S Kumar ◽  
P. B Mishra ◽  
N. Vashisht
Keyword(s):  
Research Work ◽  
Angle Of Repose ◽  
In Vitro Dissolution ◽  
Taste Masking ◽  
Dissolution Profile ◽  
Cyclodextrin Complex ◽  
Onset Of Action ◽  
Disintegration Time ◽  
Ranitidine Hydrochloride ◽  
Weight Variation

In present research work, taste masked Mouth Dissolving Tablets (MDTs) of Ranitidine Hydrochloride were designed with a view to enhance the patient compliance and provide a quick onset of action. Taste masking of the drug was done by formation of complex with β cyclodextrin. Tablets were prepared by direct compression, using superdisintegrants like crosscarmellose sodium and crosspovidone in different proportion and evaluated for the pre-compression parameters such as bulk density, compressibility, angle of repose etc. In view of the better taste palatability of such a bitter API, taste masking was carried out via making the cyclodextrin complex and sucralose was used as the sweetener to impart a palatable taste to the formulation. The prepared batches of tablets were evaluated for hardness, weight variation, friability, drug content, disintegration time and in vitro dissolution profile and found satisfactory. Among all, the formulation F7 containing 5% w/w proportion of both crosscarmellose sodium and crosspovidone was considered to be best formulation, which disintegrated completely in 19 seconds and released up to 98.38% of the drug.

Development, Formulation and Evaluation of Sustain Release Dispersible Tablet of Ornidazole

2021 ◽  
pp. 174-178
Author(s):  
Abhishek Kumar Thakur ◽  
Naveen Gupta ◽  
Dharmendra Singh Rajput ◽  
Neeraj Sharma
Keyword(s):  
Shelf Life ◽  
Bitter Taste ◽  
Research Work ◽  
Ich Guidelines ◽  
Sustain Release ◽  
Dispersible Tablet ◽  
Ftir Spectral Analysis ◽  
Wetting Time ◽  
Evaluation Parameters ◽  
The Ideal

This Present research with dispersible tablet can compromise the efficacy and safety of the treatment to children’s and geriatric patients with masking the bitter taste of drug and developing its dispersible tablet. The purpose of this research work was to develop Dispersible tablet of Ornidazole by masking the bitter taste. Tablet containing drug and excipients were prepared by direct compression method. Excipients in combinations were incorporated to achieve the aim. Effect of different combinations was studied to optimize the ideal formulation. Drug excipients interaction studies were carried out by FTIR spectral analysis. The tablets were evaluated for their hardness, wetting time, disintegrating time and dissolution parameters. It was concluded that the tablets having the combination of Dried Mucilage (obtained from dried seeds of ocimum bacilicum) and Sodium starch glycolate met all the evaluation parameters and thus selected as the optimized formulation. Optimized formulation was undergone for stability testing as a parameter to predict the shelf life as per ICH guidelines and proved for its adequate shelf life.

scholarly journals Formulation and Optimization of Orodispersible Tablet of Loratadine Using Box Behnken Design

2019 ◽  
Vol 9 (4-A) ◽  
pp. 86-94
Author(s):  
Aliasgar Kundawala ◽  
Pratik Patel ◽  
Khushbu Chauhan ◽  
Anjali Desai ◽  
Dhwani Kapadia
Keyword(s):  
Drug Release ◽  
Solid Dispersion ◽  
Angle Of Repose ◽  
Drug Dissolution ◽  
Taste Masking ◽  
Disintegration Time ◽  
Box Behnken Design ◽  
Orodispersible Tablets ◽  
Orodispersible Tablet ◽  
Wetting Time

In present study Orodispersible tablets (ORDT) of Loratadine were prepared and optimized. Solid dispersion of Loratadine- β cyclodextrin complex were prepared and used in preparation of Orodispersible tablets. Various super-disintegrating agent like Cross carmellose sodium, Cross povidone and Kyron T-314 were employed for faster disintegrating effect. The 24 factorial and Box-Behnken design were utilized to optimize the tablet formulation. The Orodispersible tablet of Loratadine was optimized by Box Behnken Design, where concentrations Kyron T-314, CRP and Pearlitol SD200 were employed and its effect on Disintegration time (DT), Wetting time (WT) and % drug release at 20 min (Q20) was evaluated. Precompression parameters like angle of repose, bulk density, % compressibility, Hausner’s ratio was studies. The different batches of Orodispersable tablets were prepared and evaluated for disintegration time, friability, wetting time and drug release studies. Different batches prepared showed disintegration time in the range of 23 ± 2.52 to 59 ± 2.64, wetting time in between 27± 0.57 to 66.3 ± 3.4, drug release (Q 20) in between 86.1 ± 0.6 to 96.7 ± 0.4 in 20 min., friability less than 1 % and hardness 3.4 to 4.2 Kg/cm2. The optimized formula when compared with marketed product it showed faster disintegration time and rapid drug dissolution in phosphate buffer 6.8. The solid dispersion of Loratadine not only helped improve in solubility but may also help in taste masking. Keywords: Orodispersible tablets, Loratadine, β cyclodextrin Solid dispersion

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.

Sign in / Sign up

Export Citation Format

Share Document