The effect of binder types on the breakage and drying behavior of granules in a semi-continuous fluid bed dryer after twin screw wet granulation

Vandevivere, L.; Denduyver, P.; Portier, Christoph; Häusler, Olaf; Beer, Thomas De; Vervaet, Chris

doi:10.1016/j.ijpharm.2022.121449

Cited by 5 publications

(5 citation statements)

References 36 publications

(49 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

Section: Discussionmentioning

confidence: 99%

“…As seen in all brands of metformin hydrochloride, low crushing strength may result from a poor choice of binding agent, low binder concentration, incorrect incorporation method, inadequately dried granules, and low compression force. 35 Disintegration plays a critical role in the release of drugs from immediate-release dosage forms. The speed at which disintegration occurs is directly linked to the rate of dissolution.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Evaluation of Seven Different Brands of Metformin Hydrochloride Tablets Available in the Market in Gondar City, Ethiopia

Flatie Alemu,

Tegegne,

Getaw

2024

DHPS

View full text Add to dashboard Cite

Background WHO estimates that 15.8% of substandard or falsified medical products are used to treat non-communicable diseases which account for 80% of the global burden including diabetes. The increased level of use of metformin hydrochloride tablets in clinical practice creates the need to monitor and ascertain the quality of the various brands available in the drug market for quality control assessment and generic substitution. This study aims to assess the pharmaceutical quality of seven brands of metformin tablets circulating in pharmacy outlets in Gondar City, North West Ethiopia. Methods Official Pharmacopoeia tests such as uniformity of weight, disintegration, assay, and dissolution tests were used to assess the physicochemical quality control parameters of metformin hydrochloride tablet brands. The unofficial tests conducted included crushing strength/hardness and friability. Results In all seven tests, the tested brands passed the BP official tests for uniformity of weight, friability, disintegration, and dissolution. Each product had a friability of less than 1% with a maximum of 0.385%. In contrast, none of the brands passed the non-official hardness test. Each product disintegrated in seven to twelve minutes, meeting the USP standards. Drug release rates in 45 min ranged from 78.9 to 92.6%, and drug content results were within the USP guidelines (96.55–102.76%). Conclusion The current study demonstrated that all seven brands of metformin hydrochloride 500 mg tablets adhered to the quality control parameters specified in the pharmacopeia, except for the hardness test across all brands.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Evaluation of Seven Different Brands of Metformin Hydrochloride Tablets Available in the Market in Gondar City, Ethiopia

Flatie Alemu,

Tegegne,

Getaw

2024

DHPS

View full text Add to dashboard Cite

show abstract

“…However, in the FBG, the drying process results in the granules’ attrition, an undesired size reduction phenomenon that results in the formation of fines, which is a quality-degrading side effect. The deteriorating effects of attrition on powder flow and granules homogeneity are previously reported [ 9 , 10 , 11 ].…”

Section: Introductionmentioning

confidence: 88%

“…This indicates that the flowability of the granules obtained by the GFBG process were significantly improved compared to flowability of the physical mixture. The firstorder polynomial equation generated by regression analysis of granules angle of repose is described by Equation (11).…”

Section: Flowability (Y 4 )mentioning

confidence: 99%

“…Angle of repose ( • ) = 29.77 -3.38 X 1 + 0.3117 X 2 (11) The regression analysis (Table 6) indicates that the amount of water had a significant effect on granules' flowability (p < 0.0001 for amount of water and p = 0.4050 for spray rate). According to the polynomial equation, the negative sign of regression coefficients (−3.38) showed that the water amount has an inverse relationship with the granule angle of repose.…”

Section: Flowability (Y 4 )mentioning

confidence: 99%

See 1 more Smart Citation

Design Space Approach for the Optimization of Green Fluidized Bed Granulation Process in the Granulation of a Poorly Water-Soluble Fenofibrate Using Design of Experiment

et al. 2022

View full text Add to dashboard Cite

In the pharmaceutical industry, the systematic optimization of process variables using a quality-by-design (QbD) approach is highly precise, economic and ensures product quality. The current research presents the implementation of a design-of-experiment (DoE) driven QbD approach for the optimization of key process variables of the green fluidized bed granulation (GFBG) process. A 32 full-factorial design was performed to explore the effect of water amount (X1; 1–6% w/w) and spray rate (X2; 2–8 g/min) as key process variables on critical quality attributes (CQAs) of granules and tablets. Regression analysis have demonstrated that changing the levels of X1 and X2 significantly affect (p ≤ 0.05) the CQAs of granules and tablets. Particularly, X1 was found to have the pronounced effect on the CQAs. The GFBG process was optimized, and a design space (DS) was built using numerical optimization. It was found that X1 and X2 at high (5.69% w/w) and low (2 g/min) levels, respectively, demonstrated the optimum operating conditions. By optimizing X1 and X2, GFBG could enhance the disintegration and dissolution of tablets containing a poorly water-soluble drug. The prediction error values of dependent responses were less than 5% that confirm validity, robustness and accuracy of the generated DS in optimization of GFBG.

show abstract

Granulation of ibuprofen/isonicotinamide co-crystals by continuous spray granulator (CTS-SGR)

Kitagawa,

Ito,

Takatsu

et al. 2023

Advanced Powder Technology

View full text Add to dashboard Cite

The effect of binder types on the breakage and drying behavior of granules in a semi-continuous fluid bed dryer after twin screw wet granulation

Cited by 5 publications

References 36 publications

Evaluation of Seven Different Brands of Metformin Hydrochloride Tablets Available in the Market in Gondar City, Ethiopia

Evaluation of Seven Different Brands of Metformin Hydrochloride Tablets Available in the Market in Gondar City, Ethiopia

Design Space Approach for the Optimization of Green Fluidized Bed Granulation Process in the Granulation of a Poorly Water-Soluble Fenofibrate Using Design of Experiment

Granulation of ibuprofen/isonicotinamide co-crystals by continuous spray granulator (CTS-SGR)

Contact Info

Product

Resources

About