Effects of granule particle size and lubricant concentration on tablet hardness containing large concentration of polymers

Rajani, C B; Kumar, Dinesh; Dwivedi, Jaya; Kumar, Jha Arvind

doi:10.1590/s2175-97902017000300149

Cited by 5 publications

(6 citation statements)

References 4 publications

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“…Both formulations had similar mean granule size below 500 µm. This falls within the acceptable limits of granule size (250 -1000 µm) for tableting (Rajani et al, 2017). The flow properties of the granules were characterised by their angle of repose value which was lower for formulation I granules (28.8 o ) compared to that of formulation II granules (33.7 o ).…”

Section: Granule and Tablet Parameters Of Paracetamol Tablet Formulationsupporting

confidence: 64%

Optimization of the Extragranular Excipient Composition of Paracetamol Tablet formulation using the Quality by Design Approach

Apeji

Ariko

Olayemi

et al. 2022

Braz. J. Pharm. Sci.

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The purpose of this study is to optimize the composition of extragranular excipients (EGE) and mixing time of granules with EGE of paracetamol tablet formulation using Design of Experiments (DoE) approach. The effect of the composition of EGE and the mixing time of granules with EGE on granule and tableting properties of paracetamol tablet formulation was investigated using a combined model of mixture and process factors (Design-Expert 12). A total of 18 tablet formulations were manufactured by wet granulation using varying compositions of EGE and varying mixing time. Granule and tablet properties of each formulation were evaluated as response variables for the design, data generated were fitted into models and analysed to generate a design space that was used for optimization studies. The proposed EGE composition as predicted by the design was confirmed and validated after preparation and evaluation of the granule and tablet properties. The optimized composition for the EGE that yielded granules and tablets of desirable characteristics was found to be maize starch (5 %), talc (4.9 %) and magnesium stearate (0.1 %) with a mixing time of 2 min. The tablets produced with the optimized composition had better mechanical strength and disintegration time than the formulation prepared using an existing formula of maize starch (7.8 %), talc (2 %) and magnesium stearate (0.2 %) that were obtained using the One Variable at a Time (OVAT) approach. This study confirmed the relevance of quality by design in development of pharmaceutical formulations.

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Section: Granule and Tablet Parameters Of Paracetamol Tablet Formulationsupporting

confidence: 64%

Optimization of the Extragranular Excipient Composition of Paracetamol Tablet formulation using the Quality by Design Approach

Apeji

Ariko

Olayemi

et al. 2022

Braz. J. Pharm. Sci.

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“…For this purpose, dissolution of solid oral drug products has emerged as a very important quality control test for assuring uniformity of product and batch-to-batch equivalence. The factors that affect dissolution include type and concentration of binder, hardness, surface area, the distance of diffusion, solubility of the drug, manufacturing process, and diluents (30,34,(41)(42)(43)(44). The dissolution may be performed by collecting one aliquot from the bath after 30 min.…”

Section: Resultsmentioning

confidence: 99%

Quality Assessment of Brands of Prednisolone (5 Mg) Tablets Marketed in Abuja Metropolis of Nigeria

Isaac¹,

Hayatu²,

John³

et al. 2021

Dissolution Technol.

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This study aims to evaluate the quality of brands of prednisolone tablets marketed in Nigeria. Quality control parameters such as weight variation, hardness, friability, disintegration, assay, and dissolution were assessed. Ten of 11 brands tested met the United States Pharmacopeia (USP) specifications for dissolution of immediate-release dosage forms at stage S1 or S2, but one brand failed to meet the requirement even at stage S3. Using a validated method, all brands except one contained the labelled drug amount per USP specifications (100 ± 10%). Seven brands failed the hardness test, but there were no issues with other parameters like friability, weight variation, and disintegration. This study demonstrates that most generics of prednisolone tablets currently circulating in Abuja, Nigeria are of good quality.

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“…Generally, as there is an increase in weight variation, there is also a decrease in hardness and an increase in friability. 21 Thus, a formulation containing a lower concentration of 3% and 5% MCC-SC produced a tablet with higher resistance to abrasion, chipping and breakage than the tablets with 7% MCC-SC that also resulted to substandard weight tablet. Formulations with MCC-SC also exhibited better disintegrating property than the formulation with commercially available MCC at 5%.…”

Section: Evaluation Of Tabletsmentioning

confidence: 98%

Evaluation of Microcrystalline Cellulose Derived from Saccharum officinarum L. (Sugarcane) Leaves as a Disintegrant in Tablet Formulations

2020

Adv Pharm Bull

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Purpose : Complete recycling of the crop residues of sugarcane in the Philippines remains to be achieved. This study purposed to derive microcrystalline cellulose (MCC) from sugarcane leaves and test its disintegrating properties in tablet formulation. Methods: Saccharum officinarum L. (sugarcane) leaves were used to prepare MCC powder. According to the conventional method, the preparation of cellulose powder requires heating the raw material with acid and alkali followed by washing, bleaching, and sieving. Hydrolysis of the bleached product was carried out using hydrochloric acid to obtain MCC powder, and the physicochemical properties of the produced MCC powder were studied including its organoleptic properties, pH value, %loss on drying, %water soluble substances and Fouriertransform infrared (FTIR) spectrum. Results: The resulting powder was evaluated for its disintegrating property in the preparation of blank tablets, which were compared to tablets prepared using commercially available MCC. MCC powder derived from sugarcane leaves had properties at par with commercially available MCC and was in conformance with National Formulary (NF) specifications. Conclusion: Disintegrating properties were also significantly better than the commercially available MCC.

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Effects of granule particle size and lubricant concentration on tablet hardness containing large concentration of polymers

Cited by 5 publications

References 4 publications

Optimization of the Extragranular Excipient Composition of Paracetamol Tablet formulation using the Quality by Design Approach

Optimization of the Extragranular Excipient Composition of Paracetamol Tablet formulation using the Quality by Design Approach

Quality Assessment of Brands of Prednisolone (5 Mg) Tablets Marketed in Abuja Metropolis of Nigeria

Evaluation of Microcrystalline Cellulose Derived from Saccharum officinarum L. (Sugarcane) Leaves as a Disintegrant in Tablet Formulations

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