Functionality of disintegrants with different mechanisms after roll compaction

Berkenkemper, Sabrina; Keizer, Hannah L.; Lindenberg, Marc; Szepes, Anikó; Kleinebudde, Peter

doi:10.1016/j.ijpharm.2020.119434

Cited by 10 publications

(2 citation statements)

References 43 publications

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“…Roller compaction granulation means that the powder mixture is compressed between two counter-rotating rollers from a dense belt press block, and then the belt is ground into granules through a screen, and the granules are further mixed with excipients to form a compressed or encapsulated mixture. The factors affecting the rolling process include the physical and mechanical properties of raw materials, such as particle size and morphology, as well as process variables, such as the feed screw speed, roll speed, roll force, roll gap, and roll surface, and the change in environmental moisture content [16] . These parameters will affect the drug strip CQAs, such as their density, porosity, strength, and drug content, thus affecting the particle CQAs (PSD, fluidity, content uniformity, and compressibility).…”

Section: Dry Granulationmentioning

confidence: 99%

Granulation process analysis technologies and potential applications in traditional Chinese medicine

Cui

Hou

Feng

et al. 2022

Acupuncture and Herbal Medicine

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Pharmaceutical production is changing from batch production to continuous production, during which granulation is one of the most important unit operations. The quality of mass-produced products is traditionally guaranteed by conducting off-line testing, which cannot meet the demand of continuous production for real-time monitoring of critical process parameters and critical quality attributes (CQAs) of the pharmaceutical granulation technology. Since the U.S. Food and Drug Administration proposed process analytical technology (PAT) in 2004, many PAT tools have been developed to monitor the granulation process and provide information regarding the granulation operation conditions and endpoint determination. In this article, we review the recent research and application of two PAT modes in the granulation process, namely, single CQA and multi-CQA PAT, with the aim to provide references for comprehensively improving the technological level of the pharmaceutical granulation process. Furthermore, the potential applications in traditional Chinese Medicine are discussed.

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Section: Dry Granulationmentioning

confidence: 99%

Granulation process analysis technologies and potential applications in traditional Chinese medicine

Cui

Hou

Feng

et al. 2022

Acupuncture and Herbal Medicine

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show abstract

“…Research Rachmawati et al (2015) states that the development of a formulation combining SSG and croscarmellose sodium will produce tablets with better physical quality parameters and can accelerate the disintegration time, dispersion time, and tablet wetting time. This study uses the direct printing method because according to Berkenkemper et al (2020), the disintegrating effect of croscarmellose sodium would be damaged due to the granulation process.…”

Section: Introductionmentioning

confidence: 99%

Optimization of Croscarmellose and Sodium Starch Glycolate on Orally Disintegrating Metoclopramide HCL Tablets

Ikasari¹,

Cahyani²,

Collusy³

2022

JFSP

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Dosage form of metoclopramide HCl which has high solubility but low permeability is Orally Disintegrating Tablet (ODT), because can decrease first-pass-effect metabolism so that its bioavailability and effectiveness increase. Superdisintegrant is an excipient that has a major role in the formulation of ODT. The combination of croscarmellose and Sodium Starch Glycolate (SSG) can accelerate tablet disintegration time so that the resulting ODT is suitable for its intended use. The purpose of this study was to determine the effect of each and the interaction of the use of croscarmellose and SSG on the physical characteristics of ODT metoclopramide HCl, and to get the optimum formula of ODT metoclopramide HCl. Tablets were prepared by direct compression method. Optimization process by using simplex lattice design (design expert 10.0.1.R program) with eight formulas, including FI (5.25%A:1.75%B), FII (0%A:7%B), FIII (7%A:0%B), FIV (1,75%A:5,25%B), FV (7%A:0%B), FVI (3.5%A:3.5%B), FVII (3.5%A:3.5%B) and FVIII (0%A:7%B). Component A is the concentration of croscarmellose and component B is the concentration of SSG. Based on SLD equation could be seen the single-use croscarmellose and SSG components be increased flowability, hardness, moisture content, friability, water ratio absorption, weight uniformity, uniformity of content, accelerate disintegration time, wetting time, and dissolution. Interaction of the two components was increased flowability, moisture content, water ratio absorption and dissolution, decreased hardness, friability, uniformity of content, weight uniformity, accelerate disintegration time, and wetting time. The optimum formula of ODT metoclopramide HCl with proportion 5.145% croscarmellose and 1.855% SSG. Based on the one sample t-test between theoretical results and the experimental results could be seen that there were no significant differences between them

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An improved method for the simultaneous determination of water uptake and swelling of tablets

Lenz

Bunjes

Kwade

et al. 2021

International Journal of Pharmaceutics

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Functionality of disintegrants with different mechanisms after roll compaction

Cited by 10 publications

References 43 publications

Granulation process analysis technologies and potential applications in traditional Chinese medicine

Granulation process analysis technologies and potential applications in traditional Chinese medicine

Optimization of Croscarmellose and Sodium Starch Glycolate on Orally Disintegrating Metoclopramide HCL Tablets

An improved method for the simultaneous determination of water uptake and swelling of tablets

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