Assessment of Physicochemical Properties and Comparison of Dissolution Profiles of Metformin Hydrochloride Tablets in Saudi Arabia

Bratty, Mohammed Al; Alhazmi, Hassan A.; Alam, Shamsher; Alam, Intakhab; Javed, Sadique A.; Alam, Nawazish

doi:10.14227/dt270120p36

Cited by 6 publications

(10 citation statements)

References 23 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…19 The study conducted on 10 brands of metformin HCL in Saudi Arabia in 2020 reported that nine of the brands were bioequivalent. 20 Whereas a study from Nigeria on eight brands of metformin HCL on the market reported that only four of them are interchangeable in clinical practice. 13 This discrepancy might be due to the inclusion of different types of brands for the study.…”

Section: Discussionmentioning

confidence: 99%

Dissolution Profile Evaluation of Eight Brands of Metformin Hydrochloride Tablets Available in Jimma, Southwest Ethiopia

Umeta

Bekele

Mohammed

et al. 2021

DMSO

View full text Add to dashboard Cite

Background: Dissolution is the critical quality control parameter and used to predict an in vivo oral bioavailability, and it is used to support bio-waiver. Aim: To evaluate and compare the dissolution profile of eight brands of metformin HCL 500 mg tablets available in Jimma town, Southwest Ethiopia. Methods: The study was conducted in Jimma town, Ethiopia. Eight (seven brands and one comparator) metformin HCL 500 mg tablets were included. The dissolution study was conducted as per United States Pharmacopeia, and the dissolution profile was compared by one-way ANOVA, model-dependent and model-independent approaches. Results: All of the included tablet brands complied with single-point dissolution study specification. Statistical comparisons of the dissolution profile by one-way ANOVA revealed that all brands had similar dissolution profiles (p=0.89). All of the brands had a similarity factor (f 2 ) >50% and the difference factor (f 1 ) <15. The entire brands followed the Weibull curve approach (the highest coefficient of determination and lowest Akaike Information Criteria) for the release of an active pharmaceutical ingredient. Conclusion:All of the brands complied with single point dissolution study and all of them could be used interchangeably with the innovator drug. All brands followed the Weibull method for the release of the drug substance.

show abstract

Section: Discussionmentioning

confidence: 99%

Dissolution Profile Evaluation of Eight Brands of Metformin Hydrochloride Tablets Available in Jimma, Southwest Ethiopia

Umeta

Bekele

Mohammed

et al. 2021

DMSO

View full text Add to dashboard Cite

show abstract

“…In vitro release studies for either milled EXTs or tablet equivalent to 23 mg of DH were performed using a USP type-II dissolution apparatus with 900 mL of a pH 6.8 phosphate buffer (simulated intestinal fluid) at 37 ± 0.5 • C and 50 rpm for 10 h [18,19]. Due to the extensive use of simulated intestinal fluid for the drug release study of oral and sustained release formulations, it was used as the biorelevant dissolution media for the drug release study in this work [18][19][20]. All dissolution samples were analyzed using an HPLC-UV system (n = 3).…”

Section: In Vitro Release Studiesmentioning

confidence: 99%

“…In addition, the statistical analysis was conducted using ANOVA to compare the release profiles. It is well-known that if the calculated f 2 value is between 50 and 100, then the profiles are considered to be similar [20]. In addition, the drug release kinetics of different EXTs were evaluated using different kinetic models such as a zero order model, first order model, the Higuchi model, the Hixson-Crowell model, and the Korsmeyer-Peppas model, as described in the literature [21].…”

Section: In Vitro Release Studiesmentioning

confidence: 99%

Development and Characterization of Sustained-Released Donepezil Hydrochloride Solid Dispersions Using Hot Melt Extrusion Technology

et al. 2021

View full text Add to dashboard Cite

The aim of this work was to develop the sustained release formulation of donepezil hydrochloride (DH) using the hot-melt extruded solid dispersion technique via the rational screening of hydrophobic carriers. Hydrophobic carriers with different physicochemical properties such as pH-independent swellability, low-permeability (Eudragit® RS PO (E-RS)), pH-independent non-swellability (ethyl cellulose N7 (EC-N7)), and the presence of lipids (Compritol® 888 ATO (C-888)) with or without pore-forming agents were used to achieve the sustained release profile of DH. Mannitol (MNT) was chosen as the temporary pore-forming agent. The thermal analysis showed that both the drug and C-888 preserved their crystallinity within a solid dispersion. During a dissolution test, MNT could generate pores, and the drug release rate was proportionally correlated to the MNT content. Tailoring of the ratio of C-888 and MNT in the formulations along with an appropriate extrusion temperature profile resulted in the modified release of DH, and a preferable release pattern was obtained under these conditions. C-888 was chosen for the further investigations to obtain tablets with a high integrity. The optimized tablets were compared to the marketed formulation of Aricept® in terms of drug release profiles. The optimized formulation showed the stable and sustained release behavior of extended release profile, which was close to the release behavior of Aricept® with good tablet characteristics. It was concluded that the hot-melt extrusion technique can be utilized for the manufacturing of DH sustained release tablets with improved tablet integrity and characteristics by co-processing the tablet excipient with DH/C-888.

show abstract

“…These solutions were analyzed by UV spectrophotometer at λ max of 255 nm. The amount of drug present in final solution and the percentage purity was determined [7].…”

Section: Drug Contentmentioning

confidence: 99%

“…Dissolution efficiency (% DE) of all brands was determined ( Fig. 3) that provides better prediction of in vivo drug release [7]. The generic products were considered to be equivalent when their DE values were closer to innovator product (% DE within ±10% is often acceptable).…”

Section: Dissolution Studiesmentioning

confidence: 99%

Quality Control Measurement and in vitro Bioequivalence of Candesartan Cilexetil Tablets Marketed in Saudi Arabia

Bratty

Alhazmi

Makeen

et al. 2020

JPRI

Self Cite

View full text Add to dashboard Cite

Aim: Some generics were reported to be counterfeit and inferior quality than the innovators. This study was aimed to make sure about the compliance with standard specifications and evaluation of the quality of different selected brands (generic and innovator), after performing different pharmacopeial quality control tests, of Candesartan cilexetil tablets (16 mg) commercially available in Saudi Arabia for hypertensive patients. Study Design: In vitro study of tablets. Place and Duration of Study: College of Pharmacy, Jazan University, Jazan, KSA, between September 2018 and May 2019. Methodology: The different generic brands of Candesartan cilexetil (CC) and innovator brand (16 mg) were subjected to weight variation, hardness, friability, assay, and disintegration tests following the established protocols. The purity of active ingredient was authenticated by comparative analysis of FT-IR spectra with pure drug. In vitro bioequivalence was studied after analyzing the results of dissolution summaries in phosphate buffer (pH 6.5) mixed with polysorbate 20 (0.35% v/v). Results: The results of the tests conducted for evaluation of the tablets were found to be in acceptable limits for all the selected brands. After comparative analysis of FT-IR spectra with pure drug, it was inferred that correct active ingredient was used for the preparation of tablets. The drug release profile exhibited 96.89 – 101.97% of release of CC from all generic brands, in comparison to 99.4% for innovator brand after 60 min of study. The assessment of difference factor (f1<15) and similarity factor (f2>50) revealed the resemblance of generic brands with that of innovator brand. Furthermore, the dissolution efficiency (DE = ±10% of the innovator value) of all generic brands (73.12 – 73.25%) exhibited equivalency with that of innovator brand (70.45%). Conclusion: The selected generics were considered to be biopharmaceutically equivalent to the innovator and maintained their efficacy. As a consequence, these brands can be used interchangeably by the hypertensive patients in Saudi Arabia.

show abstract

Assessment of Physicochemical Properties and Comparison of Dissolution Profiles of Metformin Hydrochloride Tablets in Saudi Arabia

Cited by 6 publications

References 23 publications

Dissolution Profile Evaluation of Eight Brands of Metformin Hydrochloride Tablets Available in Jimma, Southwest Ethiopia

Dissolution Profile Evaluation of Eight Brands of Metformin Hydrochloride Tablets Available in Jimma, Southwest Ethiopia

Development and Characterization of Sustained-Released Donepezil Hydrochloride Solid Dispersions Using Hot Melt Extrusion Technology

Quality Control Measurement and in vitro Bioequivalence of Candesartan Cilexetil Tablets Marketed in Saudi Arabia

Contact Info

Product

Resources

About