Characterising the disintegration properties of tablets in opaque media using texture analysis

Abstract

Tablet disintegration characterisation is used in pharmaceutical research, development, and quality control. Standard methods used to characterise tablet disintegration are often dependent on visual observation in measurement of disintegration times. This presents a challenge for disintegration studies of tablets in opaque, physiologically relevant media that could be useful for tablet formulation optimisation. This study has explored an application of texture analysis disintegration testing, a non-visual, quantitative means of determining tablet disintegration end point, by analysing the disintegration behaviour of two tablet formulations in opaque media. In this study, the disintegration behaviour of one tablet formulation manufactured in-house, and Sybedia Flashtab placebo tablets in water, bovine, and human milk were characterised. A novel method is presented to characterise the disintegration process and to quantify the disintegration end points of the tablets in various media using load data generated by a texture analyser probe. The disintegration times in the different media were found to be statistically different (P<0.0001) from one another for both tablet formulations using one-way ANOVA. Using the Tukey post-hoc test, the Sybedia Flashtab placebo tablets were found not to have statistically significant disintegration times from each other in human versus bovine milk (adjusted P value 0.1685).

Mimicking the Impact of Infant Tongue Peristalsis on Behavior of Solid Oral Dosage Forms Administered During Breastfeeding

“…The physical characterization data for the tablets, used by Scheuerle et al 16 . previously, typical for rapidly disintegrating tablets of this formulation, are summarized in Table 2.…”

“…Human milk is highly variable in composition, with protein, fat, and carbohydrate amounts varying between mothers and feeds 17 . Future tests could use human milk but would require careful matching of milk composition to ensure reproducibility of results because media composition has been shown in some studies to influence tablet disintegration 16, 18…”

“…A system like this could be useful in mimicking chewing, and therefore characterization of the effects of chewing on modified release solid dosage forms. If further developed and validated, this could potentially be a useful supplement to other forms of tablet disintegration testing13, 14, 15 and texture analysis disintegration testing 16 …”

Characterisation of zinc delivery from a nipple shield delivery system using a breastfeeding simulation apparatus

“…Milk density was measured using a hydrometer (VWR, Lutterworth, UK) at temperatures in the range produced during the simulation apparatus tests (34.4–34.7°C) which simulate mouth temperatures that could be present during NSDS use [ 17 ].…”

Comparative Dissolution and Disintegration Study of Different Brands of Linezolid 600 mg Tablets Available in Karachi, Pakistan

“…"Disintegration is a fundamental demand of tablet to convert it into small particles thereby increasing the drug's surface area, which is very much vital for gastrointestinal absorption (GI)'' . Disintegration of tablets is very essential to classify the dissolution rate and many researchers revealed disintegration as a surrogate for dissolution [16]. The disintegration test is very advantageous to estimate disintegration of tablets or capsules within specified time when interact with a solvent which is according to standards [17].…”