scholarly journals Formulation and Evaluation of Immediate Release Tablet Dosage Form of Linagliptin and Metformin Hydrochloride

2021 ◽  
Vol 11 (3-S) ◽  
pp. 61-64
Author(s):  
Rakesh Kumar Jat ◽  
Sukanta Chatterjee
Keyword(s):  
Dosage Form ◽  
Drug Product ◽  
Scale Up ◽  
Immediate Release ◽  
Fixed Dose ◽  
Metformin Hydrochloride ◽  
Solid Dosage ◽  
Model Drug ◽  
The Individual ◽  
Tablet Dosage

The aim of the current study work was to formulate and assess a fixed dose mixture tablet of instant release oral solid dosage form comprising two anti-diabetic drugs (linagliptin and metformin hydrochloride) for managing of diabetes mellitus type 2.The innovator drug product (Jentadueto Tablet) was evaluated for the various evaluation parameters, which have been taken into consideration during the drug product development. Pre-formulation evaluation was accomplished to safeguard better parameters of formulated drug product. On the result of pre-formulation evaluation and innovator drug product characterization, the model drug product was recognized in various steps. The established formulation was augmented for different excipients. The instant release film covered tablet of linagliptin and metformin HCl was expressed and augmented at laboratory scale. The individual steps (procedures) were improved for the same and the scale-up contemplation have been engaged into account certify the product performance at pilot plant-up to commercial scale-up. Keywords: anti-diabetic, linagliptin, metformin

scholarly journals Application of Fourier Transform Infrared Spectrophotometry Method for Analysis of Metformin Hydrochloride in Marketed Tablet Dosage Form

2021 ◽  
Vol 7 (2) ◽  
pp. 168-177
Author(s):  
Nerdy Nerdy ◽  
Linda Margata ◽  
Dian Ika Perbina Meliala ◽  
Bunga Mari Sembiring ◽  
Selamat Ginting ◽  
...  
Keyword(s):  
Fourier Transform ◽  
Dosage Form ◽  
Limit Of Detection ◽  
Fourier Transform Infrared ◽  
Metformin Hydrochloride ◽  
Infrared Spectrophotometry ◽  
Relative Standard ◽  
Limit Of Quantitation ◽  
The Fourier Transform ◽  
Tablet Dosage

The first line drug given for monotherapy for diabetes mellitus type 2 is metformin hydrochloride, which is a biguanide antihyperglycemic drug. The aim of this research was to develop, validate, and apply the Fourier Transform Infrared spectrophotometry method to identify and determine metformin hydrochloride in marketed tablet dosage form. This research included preparation of standard, analysis of samples, and validation of method. The specific wavenumber obtained for qualitative analysis was 1645.68 cm–1 and 1574.8 cm–1. The specific area obtained for quantitative analysis with a single baseline ranged from 1701.53 cm–1 to 1535.66 cm–1. All metformin hydrochloride marketed tablet dosage forms were analyzed and met all of the qualitative and quantitative requirements. The methods met the requirements of method validation for accuracy with a percentage of recovery of 100.22 %, precision with relative standard deviation of 0.48 %, linearity with a correlation coefficient of 0.9992, limit of detection of 11.17 mg per mL, limit of quantitation of 33.84 mg per mL, and good specificity results. In this study, the Fourier Transform Infrared spectrophotometry method was successfully developed and validated for application in identification and determination of metformin hydrochloride in marketed tablet dosage form.

SIMULTANEOUS ANALYSIS OF A THREE COMPONENT MIXTURE BY VIERODT’S SIMULTANEOUS EQUATION METHOD

INDIAN DRUGS ◽  
2016 ◽  
Vol 53 (10) ◽  
pp. 40-42
Author(s):  
A Palekar ◽  
◽  
S. Gaude ◽  
S. P. N. Pai
Keyword(s):  
Spectrophotometric Method ◽  
Dosage Form ◽  
Drug Product ◽  
Simultaneous Equation ◽  
Simultaneous Equations ◽  
Simultaneous Estimation ◽  
Component Mixture ◽  
Percent Recovery ◽  
And Performance ◽  
Tablet Dosage

A simple, rapid, sensitive and economical UV spectrophotometric method was developed and validated for the simultaneous estimation of aspirin, caffeine, and orphenadrine citrate by Vierodt’s method in combined tablet dosage form and using mixture of 0.1 N HCl: ethanol (1:1) as solvent. The method employs designing and solving of simultaneous equations using 3 wavelengths, namely 226 nm, 272 nm, and 210 nm. Beer’s law was obeyed in the concentration range of 3-18 μg/mL for aspirin and 0.5-12 μg/mL for both caffeine and orphenadrine citrate with r2 value of 0.993, 0.991, and 0.991 respectively. Accuracy was determined by recovery studies and showed percent recovery ranging from 99.78-100% for aspirin, 96.10-100.92% for caffeine and 100.53-102.5% for orphenadrine citrate. The developed method can be used in QC laboratory for routine analysis to ensure the identity, purity, and performance of the drug product.

In-Vitro Functionality of Clozapine Biphasic Release Minitablet Using Advanced Statistical Tools

2021 ◽  
Vol 11 ◽  
Author(s):  
Hardik Rana ◽  
Rushikesh Chaudhari ◽  
Vaishali Thakkar ◽  
Tejal Gandhi
Keyword(s):  
Drug Release ◽  
Sustained Release ◽  
Ethyl Cellulose ◽  
Dosage Form ◽  
Immediate Release ◽  
Solid Dosage Form ◽  
Solid Dosage ◽  
Precipitation Inhibitor

Background: The better control of the drug release with immediate effect is the major concern to achieve better therapeutic action and patient compliance. The failure of the solid dispersion complex during storage as well as in-vivo is another concern for the oral solid dosage form. Objective: The prime objective of the present study was to optimize the biphasic minitablet incorporating quality by design approach using the combination of waxy erodible and water-impermeable excipients. Exploration of Soluplus as a precipitation inhibitor and Dexolve as a solubility enhancer in oral solid dosage form was the secondary objective. Methods: The drug-Excipient compatibility study was assessed by FTIR. Clozapine was chosen as a model drug that has poor aqueous solubility. The complex was formulated using B-cyclodextrin or HP B-CD or Dexolve by kneading method. The screening of solubility enhancers and their amount were performed based on phase solubility study. The precipitation inhibitor was screened as per the parachute effect study. Immediate release minitablets were formulated using a direct compression method using different disintegrating agents. The IR minitablets were evaluated for different evaluation parameters. The sustained release minitablets was formulated by hot-melt granulation technique incorporating the Precirol ATO 5 as a waxy excipient and ethyl cellulose as water impermeable excipient. The SR minitablet was optimized using a central composite design. The amount of Precirol ATO 5 and ethyl cellulose were chosen as independent variables and % drug release at 1, 6, and 10 h was selected as responses. The designed batches were evaluated for different pre and post compressional parameters. The IR and SR minitablets were filled in a capsule as per dose requirement and evaluated for in-vitro drug release. The in-vivo plasma concentration was predicted using the Back calculation of the Wagner – Nelson approach. Results: Drug – Excipient study revealed that no significant interaction was observed. Dexolve was screened as a solubility enhancer for the improvement of the solubility of clozapine. The Soluplus was chosen as a precipitation inhibitor from the parachute effect study. The immediate-release tablet was formulated using Prosolv EASYtab SP yield less disintegration time with better flowability. The sustained release mini-tablet was formulated using Precirol ATO 5 and ethyl cellulose. Two-dimensional and three-dimensional plots were revealed the significant effect of the amount of Precirol ATO 5 and ethyl cellulose. The overlay plot locates the optimized region. The in-vitro drug release study revealed the desired drug release of the final combined formulation. The in-vivo plasma concentration-time confirms the drug release up to 12h. Conclusion: The biphasic mini-tablets were formulated successfully for better control of drug release leads to high patient compliance. The use of soluplus as a precipitation inhibitor is explored in the oral solid dosage form for a poorly aqueous drug. Prosolv EASYtab SP was incorporated in the formulation as super disintegrant. The amount of Precirol ATO 5 and ethyl cellulose had a significant effect on drug release in sustained-release minitablet. The approach can be useful in the industry.

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF TENELIGLIPTINE HYDROBROMIDE HYDRATE (TEN) AND METFORMIN HYDROCHLORIDE (MET) IN TABLET DOSAGE FORM

INDIAN DRUGS ◽  
2019 ◽  
Vol 56 (08) ◽  
pp. 49-56
Author(s):  
H Joshi ◽  
A. Khristi ◽  
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Assay Method ◽  
Metformin Hydrochloride ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Economic Method ◽  
Hplc Method Development ◽  
Tablet Dosage

A simple, accurate, precise, reproducible and economic method developed and validated for the simultaneous estimation of teneligliptine hydrobromide hydrate (TENE) and metformin hydrochloride (MET HCl) in pharmaceutical dosage form. TENE and MET HCl were estimated on Thermoscientific C18 column using mobile phase 0.01M PDP: methanol (45:55 % v/v) (pH 3.5 adjusted with 5% acetic acid) at flow rate 1.0 mL/min. Detection was carried out at 254 nm. The retention time of teneligliptine hydrobromide hydrate and metformin hydrochloride were 7.77 min and 2.64 min, respectively. The linearity was found to be 4-12 μg/mL and 100-300 μg/mL for TENE and MET HCl respectively. R2 value was found to be 0.998 and 0.995. For the assay method % recovery was found in the range of 98.16 – 101 for TENE and MET HCl. The LOD and LOQ were found to be 0.3527 and 1.0690 for TENE and 0.5077 and 1.538 for MET HCl respectively. Method was validated as per ICH guidelines.

scholarly journals A VALIDATED STABILITY INDICATING ULTRA-PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR SIMULTANEOUS DETERMINATION OF METFORMIN HYDROCHLORIDE AND EMPAGLIFLOZIN IN BULK DRUG AND TABLET DOSAGE FORM

2017 ◽  
Vol 9 (3) ◽  
pp. 45 ◽  
Author(s):  
N. Madana Gopal ◽  
C. Sridhar
Keyword(s):  
Simultaneous Determination ◽  
Dosage Form ◽  
Accurate Method ◽  
Array Detector ◽  
Metformin Hydrochloride ◽  
Control Analysis ◽  
International Conference ◽  
Stability Indicating ◽  
Tablet Dosage

Objective: To develop a simple, precise, accurate, method was developed and validated for analysis of metformin hydrochloride (MET) and empagliflozin in (EMPA) in bulk and tablet dosage form.Methods: The method used a reverse phase column, dikma C18 (50×2.1 mm, 1.8 μ), a mobile phase comprising of phosphate buffer (pH-3): methanol (30:70 v/v) flow rate of 1.0 ml/min and a detection wavelength of 240 nm using a photodiode array detector. The proposed method was validated for various parameters like linearity, precision, accuracy, robustness, ruggedness, detection, quantification limits, stability studies, formulation analysis as per International Conference on Harmonization (ICH) guidelines.Results: The retention time was found to be 1.189 min and 1.712 min for MET and EMPA respectively. The proposed method was found to be having linearity in the concentration range of 500-2500 μg/ml for MET (r2=0.989) and 5-25 μg/ml for EMPA (r2=0.994), respectively. The mean % recoveries obtained were found to be 100.35-100.48% for MET and 99.80-101.30% for EMPA respectively. Stress testing which covered acid, base, peroxide, photolytic and thermal degradation was performed on under test to prove the specificity of the method and the degradation was achieved. The developed method has been statistically validated according to International Conference on Harmonization (ICH) guidelines.Conclusion: Thus, the proposed method can be successfully applied for the stability indicating the simultaneous determination of MET and EMPA in bulk and combined tablet dosage form and in the routine quality control analysis.

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