scholarly journals In–vitro Bioequivalence Study Between four Different Marketed Formulations of Gliclazide with Sustained Release Metformin Hydrochloride Tablet as an Anti-Diabetic Drug

2020 ◽  
Vol 9 (3) ◽  
pp. 1239-1248
Keyword(s):  
Generic Drugs ◽  
Research Work ◽  
Bioequivalence Study ◽  
The United States ◽  
Generic Medicine ◽  
Metformin Hydrochloride ◽  
Dissolution Profile ◽  
Product Test ◽  
The Individual

As per the granted biowaiver by the United States Food and Drug Administration, the in-vitro method is an alternative to find out bioequivalence. In the performed study, a finished product test was performed between the brand drug and the generic drugs to find out the consistency of generic drugs. In the recent era, generic medicine is encircled all over the market to reduce the cost of medicine so that the drug to be available to all the individual in minimum prices for that In-Vitro Bioequivalence is conducted for a different formulation of drugs for the assessment of different formulation of same drugs or alike active pharmaceutical ingredients. The main objective of this study is to find out the in-vitro bioequivalence, evaluate the parameters which impact on dissolution profile, and assemble the research work.

scholarly journals FORMULATION AND EVALUATION OF METFORMIN HYDROCHLORIDE AND GLICLAZIDE SUSTAINED RELEASE BILAYER TABLETS: A COMBINATION THERAPY IN MANAGEMENT OF DIABETES

2021 ◽  
pp. 343-350
Author(s):  
RAJESWARI ALETI ◽  
SRINIVASA RAO BARATAM ◽  
BANGARUTHALLI JAGIRAPU ◽  
SRAVYA KUDAMALA
Keyword(s):  
Combination Therapy ◽  
Sustained Release ◽  
Diffusion Mechanism ◽  
Research Work ◽  
In Vitro Dissolution ◽  
Metformin Hydrochloride ◽  
Dissolution Profile ◽  
Sustained Release Formulation ◽  
Bilayer Tablets

Objective: The main objective of the present investigation is to develop a sustained-release (SR) formulation to optimize the postprandial elevation of glucose level in type 2 Diabetic subjects using combination therapy. In the present research work, bilayer sustained release formulation of metformin hydrochloride (MFH) and gliclazide (GLZ), based on monolithic-matrix technology was developed and evaluated. Methods: The formulations of metformin hydrochloride layer and gliclazide layer that contain polyox WSR coagulant and different viscosity grades of hydroxyl propyl methylcellulose (HPMC) as sustained-release matrix were prepared by direct compression and wet granulation method respectively. The bilayer tablets were prepared after carrying out the optimization of metformin layer and evaluated for various pre-compression and post-compression parameters. For the best formulation selected on basis of in vitro evaluation of tablets, Fourier-transform infrared spectroscopy (FT-IR) studies and comparison of in vitro dissolution profile of developed formulation with the innovator were performed. Results: Metformin hydrochloride and gliclazide showed sustained release of drug by diffusion mechanism and followed first-order kinetics. The best formulation of metformin hydrochloride (M7) and gliclazide (G8) show 99.93% and 99.65% of drug release in 24 h respectively. The similarity factor (f2) was 79.95 for metformin hydrochloride and 73.62 for gliclazide when compared with the innovator. Conclusion: The monolith diffusion-controlled bilayer tablets of metformin hydrochloride and gliclazide offer improved patient compliance and convenience with better postprandial hyperglycemic control with once-a-day dosing. The sustained release of the drug up to 24 h regulate antidiabetic activity round the clock with minimal side effects.

scholarly journals Formulation and evaluation of orodispersible Enalapril maleate tablets: a comparative study on natural super disintegrents and synthetic super disintegrents

2015 ◽  
Vol 1 (7) ◽  
pp. 313
Author(s):  
Kameswara Rao.S ◽  
Yusuf MD. ◽  
Saraswathi P. ◽  
Ch.R.Raghavendra Rao ◽  
Murali P. ◽  
...  
Keyword(s):  
Research Work ◽  
Hepatic Metabolism ◽  
Angle Of Repose ◽  
Dissolution Profile ◽  
Compression Technique ◽  
Disintegration Time ◽  
Enalapril Maleate ◽  
Drug Content ◽  
The Individual

The aim of the present investigation is to formulate Enalapril maleate oral disintegrating tablet by using natural and synthetic superdisintegrents..ODTs may also be used to deliver drugs to the oral cavity, for local action or, in some cases, absorption across the oral mucosa, thereby avoiding first-pass hepatic metabolism and potentially increasing the rate and extent of uptake, and reducing undesirable metabolites. The objectives of the research work is to formulate oral disintegrating tablets of Enalapril maleate by using different super disintegrates(Natural, Synthetic) in different ratio by direct compression technique and tablets were evaluated for precompressional and postcompressional Parameters such as angle of repose, bulk density, tapped density, compressibility index, drug content and in-vitro drug release study, hardness, friability, wetting time and invitro dispersion time. To study the physical characteristics of the individual drug and optimized formulations by FTIR spectroscopy. To evaluate various characteristics of the resulting tablets. Formulation CCS3, IH2 were subjected to stability Studies as per ICHguidelines at temperatures and humidity of 255C/605%RH; and 405C/755%RH.Tablets didnt reveal any appreciable changes in respect to hardness, disintegration time, drug content and dissolution profile.

Statistical assessment of in vitro drug release kinetics and quality evaluation of desloratadine orally disintegrating generic tablets available in Bangladesh

2020 ◽  
pp. 174113432094775
Author(s):  
Madhabi Lata Shuma ◽  
Shimul Halder
Keyword(s):  
Release Kinetics ◽  
The United States ◽  
Quality Parameters ◽  
In Vitro Dissolution ◽  
Dissolution Behavior ◽  
Dissolution Profile ◽  
Disintegration Time ◽  
In Vitro Drug Release ◽  
Orally Disintegrating Tablets

The objective of the present study was to compare the in vitro equivalence of different orally disintegrating tablets (ODT) of Desloratadine (DES) available in Bangladesh pharmaceutical market with the reference brand. The in vitro dissolution study was carried out using the United States Pharmacopoeia (USP) paddle method and a comparative study were also carried out with the reference brand. Other pharmacopoeial and non-pharmacopoeial quality assessment parameters including hardness, friability, water absorption ratio, and disintegration time etc. were also evaluated. From the results of the dissolution profile of the commercially available products, it found majority of the products didn’t exhibited compendial requirements in dissolution behavior to the reference brand with model-independent approach ( f2 > 50, f1 < 15) and showed statistically significant differences. Additionally, the data of different physical quality parameters revealed that all commercial products complied with the official specifications. From these findings, it could be suggested that the DES-ODT formulations’ available in the Bangladesh market could be prescribed; however additional experiments might require to clarify the interchangeability among the products.

scholarly journals Development of bio-relevant dissolution method for prognosis of In-vivo performance of Dipyridamole from modified release capsules

2020 ◽  
Vol 11 (2) ◽  
pp. 2340-2349
Author(s):  
Devi Thamizhanban ◽  
Gampa Tulja Rani ◽  
Kathiresan krishnasamy
Keyword(s):  
Oral Administration ◽  
Design Of Experiment ◽  
Generic Drugs ◽  
Test Method ◽  
Dissolution Profile ◽  
Modified Release ◽  
Dissolution Method ◽  
Media Volume

In-vitro biorelevant dissolution test method was developed for Dipyridamole in modified release multi-particulate dosage form, to simulate the product drug release after oral administration to human.  The Dipyridamole concentration in blood plasma achieved after oral administration under pre-prandial (fasting) condition were used for deriving the target dissolution profile deconvoluting the plasma concentration using numerical deconvolution technique. The fraction of drug absorbed was considered as the target dissolution profile. The drug product was tested by using the dissolution method recommended by office of generic drugs, and the dissolution results observed are not comparable with the target dissolution profile.  Dissolution method was developed using reciprocating cylinder, Bio-Dis (apparatus -3 as per USP), by simulating the pre-prandial conditions. A full factorial design of experiment was carried out to achieve the target dissolution profile. Media volume and dips per minute (DPM) are considered as main factors, in design of experiment. The dissolution results achieved with media volume 250ml and 10DPM were found to be comparable with target dissolution profile and observed with the F2 value (similarity factor) of 92%. The developed dissolution method demonstrates a very good in-vitro/in-vivo correlation under pre-prandial condition, and shall be used as a predictive in-vitro tool for evaluation Dipyridamole extended release capsules.

scholarly journals DEVELOPMENT AND CHARACTERIZATION OF ORO-DISPERSIBLE TABLETS OF METFORMIN HYDROCHLORIDE USING CAJANUS CAJAN STARCH AS A NATURAL SUPERDISINTEGRANT

2022 ◽  
pp. 139-147
Author(s):  
SONIA DHIMAN ◽  
RITCHU BABBAR ◽  
THAKUR GURJEET SINGH ◽  
SHIVANGI ANAND ◽  
ASHI MANNAN ◽  
...  
Keyword(s):  
Cajanus Cajan ◽  
Research Work ◽  
Pigeon Pea ◽  
Granular Structure ◽  
Metformin Hydrochloride ◽  
Compression Process ◽  
Disintegration Time ◽  
Orodispersible Tablets ◽  
Dispersible Tablets

Objective: The aim of the research work was to explore the use of Cajanus cajan (Pigeon pea) polysaccharide as a superdisintegrant. The novel superdisintegrant has been evaluated for its action by incorporating it into orodispersible tablets of Metformin Hydrochloride. Methods: Cajanus cajan starch was extracted from its seeds and superdisintegrant was developed by microwave modification of the extract. Various characterization tests such as gelatinization temperature, water absorption index, pH, and viscosity were used to identify the microwave-modified polysaccharide. The orodispersible tablets were made using a direct compression process employing varying concentrations of modified Cajanus cajan starch. Prepared tablets were tested for several pre and post-compression parameters and compared with a well-established synthetic superdisintegrant, sodium starch glycolate. The stability studies were conducted on an optimized formulation. Results: Fourier transform infrared spectroscopy study showed that the drug had no interactions with the microwave-modified Cajanus cajan starch. SEM confirmed that Cajanus cajan starch granules exhibited intact granular structure in oval shapes and smooth surfaces. After microwave modification, the Cajanus cajan starch component lost its granular structure, which further led to the generation of surface pores and internal channels, causing overall swelling responsible for superdisintegrant activity. The optimized formulation (ODF5) containing 15 % modified Cajanus cajan starch performed better in terms of wetting time (22.21 s), disintegration time (53.3 s), and in vitro drug release (92%), as compared to formulation prepared by synthetic superdisintegrant (ODF1). Conclusion: The present investigation concluded that modified Cajanus cajan starch has good potential as a superdisintegrant for formulating oro-dispersible tablets. Furthermore, modified Cajanus cajan starch is inexpensive, non-toxic and compatible in comparison with available synthetic superdisintegrants.

scholarly journals A Comparative Study on In-vitro Quality Control Parameters of Different Brands of Loratadine Tablets Commercially Available in Bangladesh

2021 ◽  
pp. 50-58
Author(s):  
Rosy Fatema ◽  
Sumaiya Khan ◽  
A. S. M. Roknuzzaman ◽  
Ramisa Anjum ◽  
Nishat Jahan
Keyword(s):  
Research Work ◽  
Drug Market ◽  
Quality Standard ◽  
In Vitro Dissolution ◽  
Active Principle ◽  
Dissolution Profile ◽  
Disintegration Time ◽  
Weight Variation ◽  
Local Companies

Loratadine, a second generation H1-receptor antagonist, works by blocking the action of histamine and is widely prescribed for itching, runny nose, watery eyes, and sneezing from "hay fever" and other allergic conditions. To ensure quality the main requirements for a medicinal product are safety, potency, efficacy and stability. This research work aimed to compare and assess the quality levels of different local brands of loratadine tablets available in the drug market of Bangladesh. Six different brands of loratadine 10 mg tablet manufactured by the local companies were used for the analysis. The evaluation was performed through the determination of weight variation, hardness, friability, percent potency, disintegration time, and dissolution profile in accordance with USP-NF specifications. All brands showed acceptable weight variation and % friability. The percent potency for tested samples by UV method ranges from 97.02%-108%, showing none of the brands contains less than 90% of the active principle as per the specification. The result of the physical and chemical studies, such as in-vitro dissolution, disintegration, hardness, etc., has been found to differ but lie within the specified limit. After analyzing the data obtained from the tests, it can be claimed that loratadine 10 mg tablets manufactured and marketed by several local companies in Bangladesh meet the quality standard required to achieve the desired therapeutic outcomes.

Development, Optimization, Characterization and Impact of In vitro Lipolysis on Drug Release of Telmisartan Loaded SMEDDS

2019 ◽  
Vol 9 (4) ◽  
pp. 330-340 ◽  
Author(s):  
Ravinder Verma ◽  
Deepak Kaushik
Keyword(s):  
Drug Release ◽  
Dissolution Rate ◽  
Oral Bioavailability ◽  
Research Work ◽  
Mixture Design ◽  
In Vitro Dissolution ◽  
Dissolution Profile ◽  
In Vitro Lipolysis ◽  
Globule Size

Objective: The objective of the current research is systematic optimization and development of microemulsion preconcentrates to get better solubility that results in improvement of oral bioavailability profile of Telmisartan utilizing D-optimal mixture design. Methods: Solubility studies in a variety of lipidic ingredients and optimization of formulations were carried out for the development of liquid SMEDDS. D-optimal mixture design was utilized for assessing the interaction performance of desired responses (such as % cumulative drug release and globule size) and optimized using desirability approach. The optimized batch was evaluated for its % cumulative drug release and globule size performance for determining the dissolution rate and oral bioavailability of drug. Results: The optimized batch (F-8), which contained 10% oil (Capmul MCM EP), 45% surfactant (Labrasol) and 45% co-surfactant (Transcutol HP) resulted in desired qualities of measured responses with 84.6nm globule size and 98.5% drug release within 15 minutes. Optimized SMEDDS showed brilliant goodness of fit between drug release. Stability studies indicated stability of the optimized SMEDDS batch over 3-month storage at 40°C/75% RH and improved dissolution rate in contrast to pure API. The optimized SMEDDS showed no impact of in vitro lipolysis on drug release. Conclusion: Developed and optimized SMEDDS showed improved in vitro dissolution rate and dissolution profile in contrast to pure drug. These investigations further confirm dose reduction in SMEDDS by gaining an equivalent therapeutic profile with non-SMEDDS formulation. This research work successfully shows the potential usage of SMEDDS for delivery of BCS-II class drugs.

scholarly journals In vitro quality evaluation of metformin hydrochloride tablets marketed in Addis Ababa

2019 ◽  
Vol 54 (2) ◽  
pp. 169-176
Author(s):  
H Kassahun ◽  
K Asres ◽  
A Ashenef
Keyword(s):  
Drug Release ◽  
Addis Ababa ◽  
The United States ◽  
Metformin Hydrochloride ◽  
In Vitro Drug Release ◽  
Pharmaceutical Equivalence ◽  
Significant Difference ◽  
Assess Quality

In this study, an attempt was made to assess quality as well as pharmaceutical equivalence of six brands of metformin hydrochloride tablets marketed in Addis Ababa using in vitro methods. Friability, disintegration, dissolution and assay for the content of active ingredients were evaluated using the methods described in the United States pharmacopeia (2007). All the brands of metformin hydrochloride tablets complied with the official specification for hardness, friability, disintegration and assay. Five brands of metformin hydrochloride complied with the USP dissolution tolerance limits but Metformin Denk failed to release the stated amount. Statistical comparison for in vitro drug release indicates that some of the products of metformin hydrochloride tablets showed significant difference (P<0.05), indicating difference in their in vitro drug release that might affect the in vivo bioavailability and the bioequivalence of the products. Bangladesh J. Sci. Ind. Res.54(2), 169-176, 2019

scholarly journals Comparative In Vitro Quality Evaluation of Different Brands of Ibuprofen Tablets Marketed in Mekelle, Ethiopia

2020 ◽  
Author(s):  
Brhane Gebrehiwot Welegebrial ◽  
Getu Kahsay ◽  
Tadele Eticha ◽  
Hailekiros Gebretsadik
Keyword(s):  
Quality Evaluation ◽  
The United States ◽  
Pharmaceutical Products ◽  
Dissolution Profile ◽  
Dissolution Test ◽  
Drug Content ◽  
Significant Difference ◽  
Required Quality

Abstract Objective: Quality of pharmaceutical products is required to guarantee their safety and efficacy. The aim of this study was to evaluate the physicochemical quality attributes of different brands of ibuprofen tablets marketed in Mekelle, Ethiopia. The methods stated in the British Pharmacopeia were adopted for weight uniformity, hardness, friability, disintegration test and assay of drug content. Dissolution test was also carried out as stated in the United States Pharmacopeia. To compare dissolution profile, statistical analysis of drug release at different time points were employed. Results: All the brands were found with acceptable pharmacopeial specifications for weight uniformity, friability, hardness, assay of drug content and dissolution test. Six brands fulfilled the pharmacopeial requirements of disintegration test while one brand failed to disintegrate as per the BP specification. However, there were statistically significant difference in weight, hardness, disintegration, dissolution and amount of drug content among the tested samples. Thus, from this study we can conclude that all the products fulfilled the required quality evaluation parameters as stipulated in pharmacopeias except one brand which failed the disintegration test. However, the in vitro dissolution profile indicated that there may be a potential bio-in equivalence among the pharmaceutical products.

scholarly journals Comparative In Vitro Quality Evaluation of Different Brands of Ibuprofen Tablets Marketed in Mekelle, Ethiopia

2020 ◽  
Author(s):  
Brhane Gebrehiwot Welegebrial ◽  
Getu Kahsay ◽  
Tadele Eticha ◽  
Hailekiros Gebretsadik
Keyword(s):  
Quality Evaluation ◽  
The United States ◽  
Pharmaceutical Products ◽  
Dissolution Profile ◽  
Dissolution Test ◽  
Drug Content ◽  
Significant Difference ◽  
Objective Quality

Abstract Objective Quality of pharmaceutical products is required to guarantee their safety and efficacy. The aim of this study was to evaluate the physicochemical quality attributes of different brands of ibuprofen tablets marketed in Mekelle, Ethiopia. The methods stated in the British Pharmacopeia were adopted for weight uniformity, hardness, friability, disintegration test and assay of drug content. Dissolution test was also carried out as stated in the United States Pharmacopeia. To compare dissolution profile, statistical analysis of drug release at different time points were employed.Results All the brands were found with acceptable pharmacopeial specifications for weight uniformity, friability, hardness, assay of drug content and dissolution test. Six brands fulfilled the pharmacopeial requirements of disintegration test while one brand failed to disintegrate as per the BP specification. However, there were statistically significant difference in weight, hardness, disintegration, dissolution and amount of drug content among the tested samples. Thus, from this study we can conclude that all the products fulfilled the required quality evaluation parameters as stipulated in pharmacopeias except one brand which failed the disintegration test. However, the in vitro dissolution profile indicated that there may be a potential bio-in equivalence among the pharmaceutical products.

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