Drug release from E chemistry hypromellose tablets using the Bio-Dis USP type III apparatus: An evaluation of the effect of systematic agitation and ionic strength

Asare-Addo, Kofi; Šupuk, Enes; Mahdi, Mohammed H.; Adebisi, Adeola O.; Nep, Elijah I.; Conway, Barbara R.; Kaialy, Waseem; Al-Hamidi, Hiba; Nokhodchi, Ali

doi:10.1016/j.colsurfb.2016.03.066

Cited by 7 publications

(3 citation statements)

References 52 publications

(64 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…GG and GDS are anionic polysaccharides (Nep et al, 2016) with HPMC being a non-ionic polymer (Asare-Addo et al, 2016;Streubel et al, 2000) meaning release from HPMC occurs due to pH independent swelling and erosion of its matrices when drug solubility is pH independent. However, for GG and GDS pH dependent swelling and erosion of their matrices may be expected.…”

Section: Aqueous and Hydroalcoholic Media Effect On Drug Releasementioning

confidence: 99%

The influence of hydroalcoholic media on the performance of Grewia polysaccharide in sustained release tablets

Nep

Mahdi

Adebisi

et al. 2017

International Journal of Pharmaceutics

View full text Add to dashboard Cite

Co-administration of drugs with alcohol can affect the plasma concentration of drugs in patients. It is also known that the excipients used in the formulation of drugs may not always be resistant to alcohol. This study evaluates effect of varying alcohol concentrations on theophylline release from two grades of Grewia mollis polysaccharides. X-ray microtomography showed that native polysaccharide formulation compacts were not homogenous after the mixing process resulting in its failure in swelling studies. Removal of starch from the native polysaccharide resulted in homogenous formulation compacts resistant to damage in high alcoholic media in pH 6.8 (40%v/v absolute ethanol). Destarched polymer compacts had a significantly higher hardness (375N) than that of the native polysaccharide (82N) and HPMC K4M (146N). Dissolution studies showed similarity at all levels of alcohol tested (f=57-91) in simulated gastric media (pH 1.2). The dissolution profiles in the simulated intestinal fluids were also similar (f=60-94), with the exception of the native polysaccharide in pH 6.8 (40%v/v absolute ethanol) (f=43). This work highlights the properties of Grewia polysaccharide as a matrix former that can resist high alcoholic effects therefore; it may be suitable as an alternative to some of the commercially available matrix formers with wider applications for drug delivery as a cheaper alternative in the developing world.

show abstract

Section: Aqueous and Hydroalcoholic Media Effect On Drug Releasementioning

confidence: 99%

The influence of hydroalcoholic media on the performance of Grewia polysaccharide in sustained release tablets

Nep

Mahdi

Adebisi

et al. 2017

International Journal of Pharmaceutics

View full text Add to dashboard Cite

show abstract

“…Regardless of charge sign, powders containing CR had a lower absolute net-CMR than those containing HPMC DC ( Figure 4 c,d). The addition of excipients as well as processing parameters have been reported to have an effect on the charging properties of APIs [ 26 , 28 , 29 , 32 , 33 , 49 ]. Plotting the flow rate of different samples under investigation against the net-CMR showed powder flowability to decrease with the increase in net-CMR ( Figure 4 e).…”

Section: Resultsmentioning

confidence: 99%

Imaging of the Effect of Alcohol-Containing Media on the Performance of Hypromellose Hydrophilic Matrix Tablets: Comparison of Direct Compression and Regular Grades of Polymer

et al. 2020

Self Cite

View full text Add to dashboard Cite

As the ingestion of drug products with alcohol could have adverse effects on the release of drugs from dosage forms, it is important to understand the mechanisms underpinning the influence on drug release by evaluating the effect of alcohol-containing media on the behaviour of pharmaceutical excipients. In this work, the effect of hydroalcoholic media containing up to 40% v/v absolute ethanol was evaluated, employing both the regular (CR) and direct compression grades (DC) of hypromellose. X-ray microtomography (XµT) and magnetic resonance imaging (MRI) were used as complementary techniques in determining the influence of the media composition on the ability of the CR and DC polymers to form and evolve the gel layer that controls drug release. Particle and powder properties of the polymer were characterised to determine any relationship to performance in hydroalcoholic media. Triboelectrification results showed the CR grade formulation to charge electropositively whereas the DC grade charged electronegatively. The flow properties also showed the DC grade to have a superior flow as compared to its CR counterpart. Differences in particle morphology between the grades influenced charging and flow behaviour of the powders; however, it did not seem to impact significantly either on the mechanical strength or the drug release properties of the compacted formulation using the model drug propranolol HCl. XµT and MRI imaging were successfully used as complementary techniques in determining the gel layer/hydration layer thickness measurements as the layer developed, as well as following ingress of hydroalcoholic media and its impact on the dry core. The result showed that although differences were present in the gel layer thickness potentially due to differences in particle morphology, this also did not impact significantly on the dissolution process, especially in acidic and hydroalcoholic media.

show abstract

“…Patient compliance and dosing unit burden can be reduced by combining two or more APIs in a single bilayer tablet (6)(7)(8). Therapeutic outcomes can be increased by combining the two APIs in a single unit due to their synergistic effect (9,10). As most bilayer tablets are developed as part of a Life Cycle Management Program, the bilayer technology provides a possibility of prolonging patent life of a drug product (7,11).…”

mentioning

confidence: 99%

Dissolution testing of bilayer tablets: Method development, validation and application in post-marketing quality evaluation

Khan¹,

Iqbal²

2017

Dissolution Technol.

View full text Add to dashboard Cite

Bilayer tablets are gaining importance as they provide a multilayer system for administration of incompatible or synergistic drugs and reduce the dosing unit burden. Furthermore, two different APIs or portions of an API with different release characteristics can be formulated as single unit, having different layers. Most of the research is directed towards physical stability (prevention of delamination), and simultaneous dissolution testing of different APIs in bilayer tablets has been neglected. In the present study, a method was developed for simultaneous determination of dissolution rates of clopidogrel and aspirin from bilayer tablets. Dissolution media was selected on the basis of sink conditions for both the drugs. Various experimental conditions (type of apparatus, agitation rate, and volume of dissolution media) were optimized, and the developed method was validated according to USP and ICH guidelines. Analysis of dissolution samples was carried out by HPLC using an ODS C-18 column (250 x 4.6 mm, 5 μm) as the stationary phase. The mobile phase consisted of a combination of acetonitrile, methanol, and phosphate buffer (50:7:43, v/v/v) pumped at flow rate of 2 mL/min at ambient temperature while the detector wavelength was set at 240 nm. An independent model approach was applied for comparison of dissolution profiles. The best in vitro dissolution profiles were obtained using 900 mL of hydrochloric acid (HCl) buffer (pH 3) as dissolution media held at 37 ± 2°C and stirred at 75 rpm using apparatus-II. Complete dissolution was achieved within 45 min. for both the drugs. Validation parameters revealed accuracy, precision, and robustness of the method without any interference with sample analysis. The developed method will be helpful in dissolution testing of bilayer tablets containing clopidogrel and aspirin at the level of product development and during routine quality control analysis and post-marketing surveillance studies.

show abstract

Drug release from E chemistry hypromellose tablets using the Bio-Dis USP type III apparatus: An evaluation of the effect of systematic agitation and ionic strength

Cited by 7 publications

References 52 publications

The influence of hydroalcoholic media on the performance of Grewia polysaccharide in sustained release tablets

The influence of hydroalcoholic media on the performance of Grewia polysaccharide in sustained release tablets

Imaging of the Effect of Alcohol-Containing Media on the Performance of Hypromellose Hydrophilic Matrix Tablets: Comparison of Direct Compression and Regular Grades of Polymer

Dissolution testing of bilayer tablets: Method development, validation and application in post-marketing quality evaluation

Contact Info

Product

Resources

About