In Vitro Equivalence Studies of Generic Metformin Hydrochloride Tablets and Propranolol Hydrochloride Tablets Under Biowaiver Conditions in Lagos State, Nigeria

Oyetunde, Olubukola O.; Tayo, Fola; Akinleye, M.O.; Aina, B A

doi:10.14227/dt190412p51

Cited by 8 publications

(14 citation statements)

References 9 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Nevertheless, Wong and Ngo [32] reported that even if multiple generic MH IR tablets had different dissolution profiles in vitro, the in vivo performance might not likely be diverted to a clinically significant extent. The previous conclusion was in complete accordance with Oyetunde et al [29] who discussed in their study that even if the dissolution performance of BSC class III drug products were found to be relatively slow, they may still have similar in vivo absorption.…”

Section: Beaker Methodssupporting

confidence: 87%

See 1 more Smart Citation

Comparative in Vitro Dissolution Study on Metformin Market Products Using Different Dissolution Apparatuses

Hashem

Abdou

Mursi

et al. 2019

Int J Pharm Pharm Sci

View full text Add to dashboard Cite

Objective: This study was proposed to evaluate and compare the in vitro dissolution profiles of six Metformin Hydrochloride (MH) market products.Methods: Different dissolution apparatuses (USP apparatus II, IV and beaker method) were used to evaluate the dissolution profiles (in phosphate buffer, pH 6.8) of two immediate release (IR) generic products of Metformin Hydrochloride (MH): Cidophage® 1000 mg (G1, Egyptian market) and Metformin arrow® 1000 mg (G2, French market) with respect to the reference products named Glucophage® 850 mg (R1, Egyptian market and R2, French market). In addition to a generic controlled-release (CR) product; Cidophage Retard® 850 mg (G3) versus the reference product; Glucophage XR® 1000 mg (R3) (both from Egyptian market). Dissolution efficiency (D. E.) and the similarity factor (f2) were calculated. Weight uniformity, hardness, tablet dimensions and MH content were measured. Results:Results of the three apparatuses showed that MH IR products studied (reference and generics) did not meet the 75% USP 30 specifications for MH dissolved at 30 min. For MH CR products, Glucophage XR® did not fulfill the USP release criteria, while Cidophage Retard® did. USP apparatus IV revealed the highest sensitivity and discriminative capability. Conclusion:Generally, MH IR generics (G1 and G2) might be interchangeable with the innovator product (Glucophage®). However, Cidophage Retard® might not be interchangeable with Glucophage XR®.

show abstract

Section: Beaker Methodssupporting

confidence: 87%

“…This may be due to differences in rate and extent of absorption [26], excipients and manufacturing processes [27] or the manufacturing variables such as the mixing effect and granulation procedure [7]. Few studies compared the performance of innovator and generic products of MH in different countries [26,[28][29][30][31][32][33][34][35].…”

Section: Introductionmentioning

confidence: 99%

Comparative in Vitro Dissolution Study on Metformin Market Products Using Different Dissolution Apparatuses

Hashem

Abdou

Mursi

et al. 2019

Int J Pharm Pharm Sci

View full text Add to dashboard Cite

show abstract

“…14 An in vitro dissolution study on four generic products of metformin showed that none of the four brands of metformin tested met this requirement because the innovator product and two others did not achieve 85% dissolution in 15 min. 16 In a similar study conducted by Olusola et al 17 in 2012 on eight generic products of metformin, only three met the criteria for BCS biowaiver after a physiochemical equivalence testing. Thus, using an in vitro dissolution profile as a surrogate for in vivo BE is still debatable as in vivo-in vitro correlation has not been established for metformin in most cases.…”

Section: Introductionmentioning

confidence: 88%

“…Thus, using an in vitro dissolution profile as a surrogate for in vivo BE is still debatable as in vivo-in vitro correlation has not been established for metformin in most cases. 16 Developing countries will benefit from generic products, unfortunately the resources for testing drug quality is limited. Thus, this study aimed to assess the bioavailability of generic formulations of metformin versus that of the innovator product.…”

Section: Introductionmentioning

confidence: 99%

Bioequivalence Study of Generic Metformin Hydrochloride in Healthy Nigerian Volunteers

Adegbola¹,

Awobusuyi²,

Adeagbo³

et al. 2017

Journal of Exploratory Research in Pharmacology

View full text Add to dashboard Cite

Background and objectives: Metformin is key in the management of type 2 diabetes mellitus but also represents additional financial burden, particularly with the use of branded products. The availability of generic products permits generic substitution with a much-reduced cost of treatment. However, only generic products that offer similar bioavailability with the innovator should be considered. This study was designed to assess the bioequivalence of generic metformin tablets within Nigeria.

show abstract

“…Dissolution profiles having value of f 2 equal to or greater than 50 were considered as similar and ones having value below 50 were considered statistically different from the reference. The f 2 values were calculated using the formula below as per US FDA guidelines 11,29,30 ,…”

Section: In-vitro Dissolution Testingmentioning

confidence: 99%

Untitled

2015

IJPSR

View full text Add to dashboard Cite

Amount of moisture content present in solid dosage forms plays a major role in influencing the physicochemical properties of tablets such as dissolution rate, disintegration time, hardness, etc. The aim of the current study was to investigate the effect of relative humidity (RH) exposure on various properties of acetaminophen tablets manufactured by direct compression and wet granulation methods. Microcrystalline cellulose was used as diluent and Plasdone™ K-29/32 and Kollidon® 90F as binder in different formulations. Wet granulation end point was determined using thermal effusivity measurements. Compressed tablets were exposed to 2%, 22%, 52% and 75% RH for 48 hours at room temperature (26 ± 1 0 C). Powder rheometer was used to evaluate the flow properties of granules after RH exposure.USP dissolution apparatus II was used to study the in-vitro drug release profiles after humidity exposure compared to reference. Thermal properties of different humidity exposed granules were examined by modulated differential scanning calorimetry. Tablets were further analyzed for hardness and disintegration time. The observed results suggested that the initial drug release was retarded for the directly compressed tablets with increase in RH exposure compared to wet granulated tablets where no major difference was observed. Viscosity of binder solution also played a significant role in the moisture uptake. Hardness of the directly compressed tablets was higher and also decreased with humidity exposure. The results show a comparative aspect of the influence of relative humidity on tablets manufactured by various techniques and different excipients on the performance properties of tablets. INTRODUCTION: Granulation is asn agglomeration process of smaller powder particles to form larger granules having uniform size and shape with the help of granulation binders to improve the dissolution rates, bulk density, flow properties etc.

show abstract

In Vitro Equivalence Studies of Generic Metformin Hydrochloride Tablets and Propranolol Hydrochloride Tablets Under Biowaiver Conditions in Lagos State, Nigeria

Cited by 8 publications

References 9 publications

Comparative in Vitro Dissolution Study on Metformin Market Products Using Different Dissolution Apparatuses

Comparative in Vitro Dissolution Study on Metformin Market Products Using Different Dissolution Apparatuses

Bioequivalence Study of Generic Metformin Hydrochloride in Healthy Nigerian Volunteers

Untitled

Contact Info

Product

Resources

About