Stability Study of fast Disintegrating tablets of Nisoldipine as per ICH Guidelines

2021 ◽  
pp. 5843-5844
Author(s):  
Seema Saini ◽  
Rajeev Garg
Keyword(s):  
Research Work ◽  
Storage Period ◽  
Pharmaceutical Product ◽  
Stability Study ◽  
Disintegration Time ◽  
Drug Content ◽  
Ich Guidelines ◽  
Significant Difference ◽  
Fast Disintegrating Tablet ◽  
The Stability

The stability study is a critical parameter to be evaluated in a pharmaceutical product development cycle. A pharmaceutical scientist pays a great deal of heed in testing a product stability. The present research work focused on conducting stability study of fast disintegrating tablet batch of Nisoldipine (NFDT). The various parameters evaluated were weight, hardness, friability, disintegration time, drug content and % drug released. The stability study of optimized fast disintegrating tablet batch NFDT was performed according to ICH guidelines. For the study plan, fast disintegrating tablet batch was placed in a wide mouth air tight containers, which were charged into the stability chamber. The temperature was adjusted at 40°C ± 2°C and relative humidity of 75% ± 5%. The study period was of 6 months. The fast disintegrating tablet batch NFDT did not showed any significant difference in weight, hardness, % friability and disintegration time. The drug content was also reported to be in limits of acceptance. The % drug released at various time intervals was insignificantly changed during its storage period. Hence, the prepared tablets were stable during their storage period.

scholarly journals QUANTIFICATION USING ULTRAVIOLET SPECTROSCOPY METHOD AND IN VITRO STABILITY STUDY OF NANOVESICULAR SYSTEM CONTAINING PHYTIC ACID

2018 ◽  
Vol 11 (8) ◽  
pp. 374
Author(s):  
Malti Arya ◽  
Krishna P Gupta ◽  
Shubhini A Saraf
Keyword(s):  
Zeta Potential ◽  
Phytic Acid ◽  
Uv Spectroscopy ◽  
Research Work ◽  
Stability Study ◽  
Spectroscopy Method ◽  
Stability Testing ◽  
Ich Guidelines ◽  
The Stability

Objective: The quantification of drug and stability of nanoparticulate delivery systems is one of the major apprehensions in biomedical applications. The present research work was attempted to quantify phytic acid by utilizing ultraviolet (UV) spectroscopy method and to evaluate the stability of nanovesicular (niosomes) system containing phytic acid.Methods: Niosomes containing phytic acid were developed by thin-film hydration method. Nanoformulation was subjected to stability testing as per the International Council for Harmonisation (ICH) guidelines. The formulation was stored at 30°C±2°C and 65%±5% RH, samples were withdrawn at 15th, 30th, 60th, 90th, 120th, and 180th day of analysis and examined for the integrity of vesicular/particle size, polydispersity index, zeta potential, and percent encapsulation efficiency.Results: Prepared nanoformulation displayed a straight line (y=mx+c) equation of y=−0.0309x+1.0413. Optimized batch of niosomes, which was prepared including dicetylphosphate showed zeta potential value of −36±0.36. Stability study showed that prepared niosomal formulation was stable up to 180 days at room temperature.Conclusion: Findings of the current research work suggested that UV spectroscopy method can be effectively used for the quantification of phytic acid and niosomal formulation of phytic acid. The formulation was found to be stable as per the ICH guidelines for stability testing.

scholarly journals Formulation and Evaluation of Piroxicam Fast Dissolving Tablets Using Direct Compression and Sublimation Method

2020 ◽  
Vol 10 (3-s) ◽  
pp. 17-25
Author(s):  
Inder Kumar ◽  
Dipima Chaudhary ◽  
Bhumika Thakur ◽  
Vinay Pandit
Keyword(s):  
Drug Release ◽  
Research Work ◽  
Stability Study ◽  
Drug Dissolution ◽  
Direct Compression ◽  
Compression Technique ◽  
Disintegration Time ◽  
Sublimation Method ◽  
The Stability

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.

scholarly journals Formulation and Evaluation of Liquisolid Compacts of Zotepine

2021 ◽  
Vol 69 (2) ◽  
Author(s):  
Dipal M. Patel ◽  
Twinkal J. Patel ◽  
Sanjesh G Rathi ◽  
Shrenik K. Shah
Keyword(s):  
Dissolution Rate ◽  
Research Work ◽  
Stability Study ◽  
Drug Solubility ◽  
Disintegration Time ◽  
Coating Agent ◽  
Drug Content ◽  
Sodium Starch Glycolate ◽  
Acceptance Range ◽  
Liquisolid Compacts

The aim of present research work is to formulation and evaluates Liquisolid Compacts of Zotepine to improve solubility and dissolution rate of drug. Solubility and dissolution rate of Zotepine was increased by preparing Liquisolid Compacts of Zotepine using PEG as vehicle, Aerosil as coating agent and Avicel as adsorbent and sodium starch glycolate as super disintegrant. FTIR study was checked for possible drug excipient interaction. The hardness of all formulation was found good enough to pass the friability criteria. Hence the friability of the formulation is well within the acceptance criteria. The friability was found less than 1 in all formulations. Further, the drug content of the formulation batches F1-F8 found within acceptance range. The disintegration time of the F1-F8 batches was found less the 60 seconds. It was found that the amount of SSG is directly affecting to DT time of formulation. The F8 formulation was found stable for 1 month during stability study. Liquisolid Compacts of Zotepine were successfully developed by using PEG as vehicle, Aerosil as coating agent and Avicel as adsorbent and sodium starch glycolate as super disintegrant.

scholarly journals A Fast and Validated HPLC Method for Simultaneous Determination of Dopamine, Dobutamine, Phentolamine, Furosemide, and Aminophylline in Infusion Samples and Injection Formulations

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Fuchao Chen ◽  
Baoxia Fang ◽  
Sicen Wang
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Stability Study ◽  
Precision Data ◽  
Column Temperature ◽  
Ich Guidelines ◽  
Limit Of Quantitation ◽  
The Stability

A simple, fast, and validated HPLC method was developed for the simultaneous quantization of five cardiovascular agents: dopamine (DPM), dobutamine (DBM), phentolamine (PTM), furosemide (FSM), and aminophylline (APL) either in infusion samples or in an injection dosage form. The proposed method was achieved with a 150 mm × 4.6 mm, 5.0 μm C18 column, by using a simple linear gradient. Mobile phase A was buffer (50 mM KH2PO4) and mobile Phase B was acetonitrile at a flow rate of 1.0 mL/min. The column temperature was kept at 30°C, and the injection volume was 20 μL. All analytes were separated simultaneously at a retention time (tr) of 3.93, 5.84, 7.06, 8.76, and 9.67 min for DPM, DBM, PTM, FSM, and APL, respectively, with a total run time of less than 15.0 min. The proposed method was validated according to ICH guidelines with respect to accuracy, precision, linearity, limit of detection, limit of quantitation, and robustness. Linearity was obtained over a concentration range of 12.0–240.0, 12.0–240.0, 20.0–200.0, 6.0–240.0, and 10.0–200.0 μg/mL DPM, DBM, PTM, FSM, and APL, respectively. Interday and intraday accuracy and precision data were recorded in the acceptable limits. The new method has successfully been applied for quantification of all five drugs in their injection dosage form, infusion samples, and for evaluation of the stability of investigated drugs in mixtures for endovenous use. The results of the stability study showed that mixtures of DPM, DBM, PTM, FSM, and APL in 5% glucose or 0.9% sodium chloride injection were stable for 48 hours when stored in polypropylene syringes at 25°C.

scholarly journals STABILITY STUDY OF AMLODIPINE BESYLATE AND BISOPROLOL FUMARATE IN AQUEOUS SOLUTIONS

2014 ◽  
Vol 5 (2) ◽  
Author(s):  
Irena Kasagić Vujanović ◽  
Dijana Jelić ◽  
Vesna Antunović ◽  
Biljana Jančić Stojanović ◽  
Darko Ivanović
Keyword(s):  
Relevant Information ◽  
Pharmaceutical Product ◽  
Stability Study ◽  
Amlodipine Besylate ◽  
Time Intervals ◽  
Constant Rate ◽  
Different Temperatures ◽  
The Media ◽  
Two Temperatures ◽  
The Stability

Valuable information concerning stability of compounds can be obtained by using different media (water, hydrochloric acid or sodium hydroxide) for dissolution of active pharmaceutical substances. Furthermore, additional knowledge is gained by performing experiments at different temperatures. This research paper deals with the stability of amlodipine besylate and bisoprolol fumarate in different media at different temperatures, whereby certain conclusions are drawn. For stability assessment, chemical kinetics approach was used, and constant rate (k), half-time (t1/2) and activation energy (Ea) were used for prediction of compound stability degree. The stability of amlodipine besylate and bisoprolol fumarate were tested, both separately and in mixture, in water and in 0.01M HCl. All the investigated solutions were treated at two temperatures 25° and 70°C at the following time intervals: 0, 1 h, 24 h, 48 h and 72 h. Hydrophilic Interaction Liquid Chromatography – HILIC method, previously developed and validated, was used. On the basis of obtained results it was concluded that amlodipine-besylate was more stable in water than in acid medium, more stable in mixture rather than individually and more stable at lower temperatures. This was confirmed by the obtained values of monitored parameters: amlodipine besylate Ea = 30.68 kJ mol-1, k (25 °C) = 0.000333 mM h-1, k (70 °C) = 0.00169 mM h-1; amlodipine besylate in mixture Ea = 42,414 kJ mol-1, k (25 °C) = 1.27∙10-4 mM h-1, k (70 °C) = 0.0012 mM h-1. Based on the obtained approximate Ea value for bisoprolol fumarate in acid (59 kJ mol-1) and in water (56 kJ mol-1), bisoprolol fumarate showed excellent stability against the media in which it was studied. On the other hand, the temperature had a significant effect on the stability of bisoprolol fumarate. These results provide the relevant information about the stability of the tested active substances, and may be of importance during the development of an appropriate pharmaceutical product. A bigger influence on the stability of bisoprolol fumarate had a temperature effect.

scholarly journals DESIGN, DEVELOPMENT AND EVALUATION OF MOUTH DISSOLVING TABLETS OF TOFACITINIB CITRATE

2022 ◽  
pp. 238-245
Author(s):  
MEGHANA RAYKAR ◽  
MALARKODI VELRAJ
Keyword(s):  
Drug Release ◽  
Stability Study ◽  
In Vitro Dissolution ◽  
Design Development ◽  
Disintegration Time ◽  
Drug Content ◽  
Weight Variation ◽  
Wetting Time ◽  
Bulk Drug

Objective: This study aims to Formulate Mouth Dissolving Tablets (MDTs) of Tofacitinib Citrate with the increase in bioavailability and patient compliance. Methods: Mouth Dissolving Tablets (MDTs) of Tofacitinib Citrate were developed by full factorial design at 32levelsand prepared by direct compression method using super integrants like sodium starch glycolate, Ludiflash. The tablets were compressed into compacts on a 10 station tablet machine. The bulk drug was characterised by determining, MP, Solubility, pH and FTIR spectra. Results: The weight variation, hardness and diameter, thickness, friability, drug content, wetting time, in vitro disintegration time and in vitro dissolution studies, and stability study, tablet thickness, weight variation and drug content post compression parameters remained consistent and reproducible. All the formulations showed, almost 100 percent of drug release within 75 min. Formulations F1, F2 and F3 were prepared with 5 mg of SSG and 20 mg, 30 mg, and 40 mg Ludiflash which shows % release of drug in the order of F1<F2<F3. Formulations F4, F5 and F6 were prepared with 10 mg of SSG and 20 mg, 30 mg, and 40 mg Ludiflash which shows % release of drug in the order of F4<F5<F6. Formulations F7, F8 and F9 were prepared with 15 mg of SSG and 20 mg, 30 mg, and 40 mg Ludiflash which shows % release of drug in the order of F7<F8<F9. Conclusion: It is concluded that the amount of superdisintegrants decreases disintegration time of tablets, decreases wetting time, increases the cumulative % drug release causes better absorption.

scholarly journals Formulation and Evaluation of Fast Dissolving Film of Losartan Potassium

2021 ◽  
Vol 68 (1) ◽  
Author(s):  
Bhageerathy A ◽  
Sandhya Murali ◽  
eny Sara Thomas ◽  
Sigi Vasanthkumar ◽  
Prasanth V V
Keyword(s):  
Drug Release ◽  
Physical Stability ◽  
Losartan Potassium ◽  
In Vivo Studies ◽  
Disintegration Time ◽  
Drug Content ◽  
Weight Variation ◽  
Significant Difference

A total of nine formulations of fast dissolving films of Losartan Potassium were developed by solvent casting method using film forming polymers such as HPMC E5, E15 and E50 and other film modifiers. The appearances of films were transparent, thin, flexible, elastic, smooth and transparent. The weight variation ranged between 16.14 ± 0.192 and 17.31 ± 0.313 and showed that there was no significant difference in the weight of individual formulations. All the formulations showed more than 150 of folding endurance. The drug content was found to be in an acceptable range for all the formulations which indicated uniform distribution of drug. A rapid dissolution of all the film was observed by the dissolution test, in which above 90% of Losartan Potassium was released within 5 min. The formulation F1 showed maximum drug release (98.73) within 5 minutes. Based on the in vitro drug release, drug content and in vitro disintegration time it is found that F1 was selected as the best formulation. The formulations showed satisfactory physical stability at 40°C at 75 % RH. Losartan Potassium (LOSAR-25) is shown in Figure 4. From the results of comparative studies of marketed product and it found that F1 showed 98.73% release within 5 min and LOSAR 25 showed 90.76% release in 30 min. In vitro studies indicate that this potential drug delivery system has considerably good stability and release profile. Nevertheless, further in vivo studies are warranted to confirm these results.

scholarly journals Oral Formulation of Anticancer Agents for Colon Cancer

2021 ◽  
pp. 402-418
Author(s):  
Dipti Patel ◽  
Krishna Patel
Keyword(s):  
Colon Cancer ◽  
Particle Size ◽  
Anticancer Agents ◽  
Crosslinking Agent ◽  
Entrapment Efficiency ◽  
Stability Study ◽  
Inlet Temperature ◽  
Disintegration Time ◽  
Drug Content ◽  
Enteric Coated

Aims/Objective: To develop and estimate enteric-coated capsules containing mucoadhesive Microspheres of Capecitabine and Oxaliplatin to treat Colon cancer. Study Design: Box Behnken. Place and Duration of Study: Department of Pharmaceutics, Parul Institute of Pharmacy and Research, Parul University, Vadodara, between 2017 to 2021. Methodology: Capecitabine and Oxaliplatin are used as antineoplastic agents and can be delivered via the oral route of administration. For the estimation of drugs Analytical method has been developed by HPLC. Box Behnken design has been used to optimize Drug: polymer ratio (1:2), Inlet temperature 170ºC, and crosslinking agent with a 0.5 ml 1% Gluteraldehyde solution. The microspheres were successfully prepared by using the spray drying technique and evaluated. Results: The results of optimized Capecitabine microspheres were obtained as Particle size 87.91 µm ± 0.274,% yield 57.21± 1.5,% Mucoadhesion 57.21± 1.5,% entrapment efficiency 82.16± 0.725. The results of optimized Oxaliplatin microspheres were obtained as Particle size 99.88µm±0.034,% yield 56.0± 0.088,% Mucoadhesion 87.0± 0.80,% entrapment efficiency 82.61±0.085. The drug content of Capecitabine and Oxaliplatin in the filled capsule was 94.67% ±0.32 and 93.45%±0.712, respectively. % Drug release of Capecitabine and Oxaliplatin in Phosphate buffer pH 7.4 was found to be 94.83±0.22 and 96.94±0.11 respectively after 8 hrs. Stability study at 400C±20C / 75 ± 5 % RH revealed that there was no significant change in disintegration time, drug content and % CDR during 6 months. So, prepared formulation was stable during stability study.  MTT assay has been performed on the formulation of Capecitabine and Oxaliplatin microspheres for assessing the % viability of both the drugs on the Caco-2 cell line. Conclusion: The present study confirmed that prepared mucoadhesive microspheres filled with enteric-coated capsules have an antitumor effect on colon cancer cells. The formulation induced high cell death within 48 hours, and less cell viability was obtained compared to API. Six months accelerated Stability study indicates that formulation is fairly stable at storage conditions.

Development and Evaluation of Fast dissolving Film of Fluoxetine hydrochloride

2021 ◽  
pp. 5345-5350
Author(s):  
Vedanshu Malviya ◽  
Srikant Pande
Keyword(s):  
Stability Study ◽  
In Vitro Dissolution ◽  
Content Uniformity ◽  
Potential Candidate ◽  
Disintegration Time ◽  
Surface Ph ◽  
Drug Content ◽  
Fluoxetine Hydrochloride ◽  
Folding Endurance

The intention of the present study was to formulate the oral dispersible film of Fluoxetine hydrochloride using pullulan as a polymer and to evaluate it with the different parameters. The drug-excipients studies were carried out in order to determine any type of incompatibilities by using Fourier transmission infrared spectroscopy (FT-IR). The oral dispersible films were prepared using solvent casting method using pullulan as a polymer. Glycerin was used as a plasticizer. The prepared films were evaluated for the parameters like physical appearance, thickness, folding endurance, In-vitro disintegration, mechanical properties, surface pH, drug content uniformity, taste evaluation, In-vitro dissolution test and stability study. The X5 formulation was found to be stable and appropriate in its evaluation parameters than compared to other formulations. The folding endurance was found to be 259±2.53, disintegration time was found to be 04±0.69, thickness was found to be 0.081±0.003, tensile strength was found to be 5.55, the % elongation was found to be 27.50, the maximum percentage drug release was found to be 95.80% in 30 minutes. The drug content was found to be 99.86 with surface pH of 6.8. In the stability studies of the formulation the product was found to be stable for 90 days. The oral dispersible film is simple to administer and very much effective for the patients and the prepared film of fluoxetine hydrochloride proves to be potential candidate for safe and effective oral dispersible drug delivery.

scholarly journals Formulation and Evaluation of Mouth Dissolving Film of Prochlorperazine Maleate

2019 ◽  
Vol 9 (6) ◽  
pp. 110-115
Author(s):  
Rajat Pawar ◽  
Ravi Sharma ◽  
Gajanan Darwhekar
Keyword(s):  
Oral Bioavailability ◽  
Research Work ◽  
Stability Study ◽  
In Vitro Dissolution ◽  
Onset Of Action ◽  
Disintegration Time ◽  
Weight Variation ◽  
Two Factors ◽  
Experimental Trials

This research work was aimed to enhance the oral bioavailability and provide faster onset of action of Prochlorperazine maleate (used for the treatment nausea and vomiting) by formulating its mouth dissolving film (MDF). Prochlorperazine belongs to BCS II and oral bioavailability of it’s about 11-15%. The MDF of Prochlorperazine  maleate was prepared by solvent casting  method using HPMC (film forming agent),Glycerol (plasticizer), Betacyclodextrin (solubilizing agent), Citric acid (saliva stimulating agent), Mannitol (sweetening agent). The formulation was optimized by two factors, three levels (32) was used for the formulation optimization of fast dissolving film of Prochlorperazine maleate and experimental trials are performed on all 9 formulation. In which the amount of HPMC, Glycerol were selected as independent variables (factor) varied at three different level: low (-1), medium (0), and high (+1) levels. The drug release and disintegration time used as dependent variables (response). and formulation was evaluated for weight variation, thickness, folding endurance, drug content, in- vitro disintegration, in vitro dissolution study and stability study. Based on results it was concluded that MDF (F3) showed enhanced bioavailability and faster onset of action. Keywords: Prochlorperazine maleate, Mouth dissolving film, bioavailability

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