Development of a Novel Method Utilising Dissolution Imaging for the Measurement of Swelling Behaviour in Hydrophilic Matrices

Overview

Journal Int J Pharm X

Specialty Pharmacology

Date 2019 Sep 14

PMID 31517278

Citations 4

Authors

Adam Ward

Karl Walton

Nihad Mawla

Waseem Kaialy

Lande Liu

Peter Timmins

Barbara R Conway

Kofi Asare-Addo

Affiliations

Soon will be listed here.

Abstract

A variety of imaging techniques are currently used within the field of pharmaceutics to help understand and determine a wide range of phenomena associated with drug release from hydrophilic matrix tablets. This work for the first time aims at developing an appropriate testing imaging methodology using a surface dissolution imaging instrument (SDI2) for determining the swelling of whole compacts using hypromellose as a model hydrophilic matrix former. The influence of particle morphology (CR and DC grades) and two compressional forces (5 and 15 kN) on the initial swelling behaviour of hypromellose were investigated. The results showed that a lower absorbance of 50 mAu with a wider measurement zone proved successful in determining the edge of the gel layer and growth measurements in real-time with high level of details under flow. Despite the differences in the morphology of the grades of hypromellose tested, it was however discovered that gel growth was statistically similar between them which may be attributed to their similar chemistry. This novel method also highlighted differences in the hydrated polymer's appearance which may have been as a result of differences in porosity and solid fraction. This information is of great importance to a formulator as gel growth plays a crucial role in determining drug release from polymer compacts.

Citing Articles

Model-Informed Drug Development: In Silico Assessment of Drug Bioperformance following Oral and Percutaneous Administration.

Djuris J, Cvijic S, Djekic L Pharmaceuticals (Basel). 2024; 17(2).

PMID: 38399392 PMC: 10892858. DOI: 10.3390/ph17020177.

New Insight into the Impact of Effervescence on Gel Layer Microstructure and Drug Release of Effervescent Matrices Using Combined Mechanical and Imaging Characterisation Techniques.

Chaiya P, Rojviriya C, Pichayakorn W, Phaechamud T Pharmaceutics. 2022; 14(11).

PMID: 36365118 PMC: 9694726. DOI: 10.3390/pharmaceutics14112299.

Application of Focus Variation Microscopy and Dissolution Imaging in Understanding the Behaviour of Hydrophilic Matrices.

Ward A, Brown B, Walton K, Timmins P, Conway B, Asare-Addo K Pharmaceutics. 2020; 12(12).

PMID: 33260657 PMC: 7759878. DOI: 10.3390/pharmaceutics12121162.

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.

Mawla N, Hanley S, Walton K, Kaialy W, Hussain T, Ward A Pharmaceutics. 2020; 12(9).

PMID: 32961942 PMC: 7559722. DOI: 10.3390/pharmaceutics12090889.

References

Tomer G, Newton J, Kinchesh P . Magnetic resonance imaging (MRI) as a method to investigate movement of water during the extrusion of pastes. Pharm Res. 1999; 16(5):666-71. DOI: 10.1023/a:1018864322400. View

Heng P, Chan L, Easterbrook M, Li X . Investigation of the influence of mean HPMC particle size and number of polymer particles on the release of aspirin from swellable hydrophilic matrix tablets. J Control Release. 2001; 76(1-2):39-49. DOI: 10.1016/s0168-3659(01)00410-2. View

Li C, Martini L, Ford J, Roberts M . The use of hypromellose in oral drug delivery. J Pharm Pharmacol. 2005; 57(5):533-46. DOI: 10.1211/0022357055957. View

Pygall S, Whetstone J, Timmins P, Melia C . Pharmaceutical applications of confocal laser scanning microscopy: the physical characterisation of pharmaceutical systems. Adv Drug Deliv Rev. 2007; 59(14):1434-52. DOI: 10.1016/j.addr.2007.06.018. View

Kaunisto E, Abrahmsen-Alami S, Borgquist P, Larsson A, Nilsson B, Axelsson A . A mechanistic modelling approach to polymer dissolution using magnetic resonance microimaging. J Control Release. 2010; 147(2):232-41. DOI: 10.1016/j.jconrel.2010.07.102. View

Ostergaard J, Meng-Lund E, Larsen S, Larsen C, Petersson K, Lenke J . Real-time UV imaging of nicotine release from transdermal patch. Pharm Res. 2010; 27(12):2614-23. DOI: 10.1007/s11095-010-0257-9. View

Kulinowski P, Dorozynski P, Mlynarczyk A, Weglarz W . Magnetic resonance imaging and image analysis for assessment of HPMC matrix tablets structural evolution in USP Apparatus 4. Pharm Res. 2010; 28(5):1065-73. PMC: 3073048. DOI: 10.1007/s11095-010-0357-6. View

Avalle P, Pygall S, Gower N, Midwinter A . The use of in situ near infrared spectroscopy to provide mechanistic insights into gel layer development in HPMC hydrophilic matrices. Eur J Pharm Sci. 2011; 43(5):400-8. DOI: 10.1016/j.ejps.2011.05.013. View

Pajander J, Baldursdottir S, Rantanen J, Ostergaard J . Behaviour of HPMC compacts investigated using UV-imaging. Int J Pharm. 2012; 427(2):345-53. DOI: 10.1016/j.ijpharm.2012.02.034. View

10.

Hulse W, Gray J, Forbes R . A discriminatory intrinsic dissolution study using UV area imaging analysis to gain additional insights into the dissolution behaviour of active pharmaceutical ingredients. Int J Pharm. 2012; 434(1-2):133-9. DOI: 10.1016/j.ijpharm.2012.05.023. View

11.

Avalle P, Pygall S, Pritchard J, Jastrzemska A . Interrogating erosion-based drug liberation phenomena from hydrophilic matrices using near infrared (NIR) spectroscopy. Eur J Pharm Sci. 2012; 48(1-2):72-9. DOI: 10.1016/j.ejps.2012.09.010. View

12.

Asare-Addo K, Kaialy W, Levina M, Rajabi-Siahboomi A, Ghori M, Supuk E . The influence of agitation sequence and ionic strength on in vitro drug release from hypromellose (E4M and K4M) ER matrices--the use of the USP III apparatus. Colloids Surf B Biointerfaces. 2013; 104:54-60. DOI: 10.1016/j.colsurfb.2012.11.020. View

13.

Boetker J, Rantanen J, Rades T, Mullertz A, Ostergaard J, Jensen H . A new approach to dissolution testing by UV imaging and finite element simulations. Pharm Res. 2013; 30(5):1328-37. DOI: 10.1007/s11095-013-0972-0. View

14.

Haaser M, Gordon K, Strachan C, Rades T . Terahertz pulsed imaging as an advanced characterisation tool for film coatings--a review. Int J Pharm. 2013; 457(2):510-20. DOI: 10.1016/j.ijpharm.2013.03.053. View

15.

Nokhodchi A, Raja S, Patel P, Asare-Addo K . The role of oral controlled release matrix tablets in drug delivery systems. Bioimpacts. 2013; 2(4):175-87. PMC: 3648939. DOI: 10.5681/bi.2012.027. View

16.

Asare-Addo K, Conway B, Larhrib H, Levina M, Rajabi-Siahboomi A, Tetteh J . The effect of pH and ionic strength of dissolution media on in-vitro release of two model drugs of different solubilities from HPMC matrices. Colloids Surf B Biointerfaces. 2013; 111:384-91. DOI: 10.1016/j.colsurfb.2013.06.034. View

17.

Yassin S, Su K, Lin H, Gladden L, Zeitler J . Diffusion and swelling measurements in pharmaceutical powder compacts using terahertz pulsed imaging. J Pharm Sci. 2015; 104(5):1658-67. PMC: 4415463. DOI: 10.1002/jps.24376. View

18.

Asare-Addo K, Supuk E, Al-Hamidi H, Owusu-Ware S, Nokhodchi A, Conway B . Triboelectrification and dissolution property enhancements of solid dispersions. Int J Pharm. 2015; 485(1-2):306-16. DOI: 10.1016/j.ijpharm.2015.03.013. View

19.

Ervasti T, Simonaho S, Ketolainen J, Forsberg P, Fransson M, Wikstrom H . Continuous manufacturing of extended release tablets via powder mixing and direct compression. Int J Pharm. 2015; 495(1):290-301. DOI: 10.1016/j.ijpharm.2015.08.077. View

20.

Khaled S, Burley J, Alexander M, Yang J, Roberts C . 3D printing of five-in-one dose combination polypill with defined immediate and sustained release profiles. J Control Release. 2015; 217:308-14. DOI: 10.1016/j.jconrel.2015.09.028. View