Correlation between critical material attributes of hydroxypropyl methyl cellulose type 2910 and film coating performance

CAI Naicong; SUN Mengjuan; GUO Yumeng; BI Yong; TU Jiasheng; SUN Chunmeng

doi:10.11665/j.issn.1000-5048.2023121504

Journal of China Pharmaceutical University > 2024 > 55(6): 758-766. > DOI: 10.11665/j.issn.1000-5048.2023121504

CAI Naicong, SUN Mengjuan, GUO Yumeng, et al. Correlation between critical material attributes of hydroxypropyl methyl cellulose type 2910 and film coating performance[J]. J China Pharm Univ, 2024, 55(6): 758 − 766. DOI: 10.11665/j.issn.1000-5048.2023121504

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Correlation between critical material attributes of hydroxypropyl methyl cellulose type 2910 and film coating performance

1.
NMPA Key Laboratory for Research and Evaluation of Pharmaceutical Preparations and Excipients, Center for Research Development and Evaluation of Pharmaceutical Excipients and Generic Drugs, Department of Pharmaceutics, School of Pharmacy, China Pharmaceutical University, Nanjing 210009
2.
Anhui Sun Here Pharmaceutical Excipients Co., Ltd., Huainan 232000, China

Funds: This study was supported by the National Pharmacopoeia Commission's 2021 Research Topics on the Formulation and Revision of National Drug Standards (2021Y23)

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Received Date: December 14, 2023

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Abstract

Abstract

To better promote the development of film-coated formulations and membrane agents, the present study was carried out to investigate the critical material attributes (CMAs) of different sources and models of HPMC in terms of film-coating performance and the correlation between each of the CMAs and the film-coating-related properties, using 2910 HPMC as the research target. Firstly, various analytical techniques were used to characterize the CMAs and film coating-related properties of HPMC. Secondly, the CMAs and film coating-related properties of HPMC were systematically evaluated by principal component analysis (PCA) and orthogonal partial least-squares discrimination analysis (OPLS-DA). The CMAs and film-coating-related properties of HPMC were systematically evaluated to elucidate the intrinsic relationship between the CMAs and film-coating-related properties of HPMC. The results showed that there were significant differences in viscosity, weight-average molecular weight, film tensile strength, elongation, elastic modulus, dissolution time, and flexibility of HPMCs from different manufacturers. The results of PCA and OPLS-DA analyses indicated that these 11 variables showed some correlations with each other. Both mathematical models showed better differentiation and classification of HPMC samples, and the OPLS-DA model had a better classification effect than the PCA model. Therefore, in this study, the physicochemical properties and the film-forming characteristic of HPMC were comprehensively evaluated, and the correlation between them was further established using PCA and OPLS-DA. The impact degree of different CMAs on the film coating performance of HPMC was clarified, which can be used as an important reference for the selection of excipient quality control programs in excipient production and formulation research and development.

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References

[1]	Alt N, Zhang TY, Motchnik P, et al. Determination of critical quality attributes for monoclonal antibodies using quality by design principles[J]. Biologicals, 2016, 44(5): 291-305. doi: 10.1016/j.biologicals.2016.06.005
[2]	Maguire J, Peng D. How to identify critical quality attributes and critical process parameters[C]//Office of Process and Facility (OPF) OPQ/CDER/FDA, FDA/PQRI 2nd conference, North Bethesda, MD. 2015.
[3]	Alhayali A, Vuddanda PR, Velaga S. Silodosin oral films: development, physico-mechanical properties and in vitro dissolution studies in simulated saliva[J]. J Drug Deliv Sci Technol, 2019, 53: 101122. doi: 10.1016/j.jddst.2019.06.019
[4]	Sakata Y, Shiraishi S, Otsuka M. A novel white film for pharmaceutical coating formed by interaction of calcium lactate pentahydrate with hydroxypropyl methylcellulose[J]. Int J Pharm, 2006, 317(2): 120-126. doi: 10.1016/j.ijpharm.2006.02.058
[5]	Nanda A, Das S, Sahoo R, et al. Aspirin-hydrogel ocular film for topical delivery and ophthalmic anti-inflammation[J]. J Serb Chem Soc, 2022, 87(7/8): 829-843.
[6]	Tran PHL, Tran TTD. The use of natural materials in film coating for controlled oral drug release[J]. Curr Med Chem, 2021, 28(9): 1829-1840. doi: 10.2174/0929867327666200312113547
[7]	Pichayakorn W, Panrat K, Suksaeree J, et al. Propranolol hydrochloride film coated tablets using natural rubber latex blends as film former[J]. J Polym Environ, 2022, 30(3): 925-937. doi: 10.1007/s10924-021-02250-y
[8]	Honary S, Golkar M. Effect of polymer grade and plasticizer molecular weights on viscoelastic behavior of coating solutions[J]. Iran J Pharm Res, 2003, 2(2): 125.
[9]	Marron JS, Alonso AM. Overview of object oriented data analysis[J]. Biom J, 2014, 56(5): 732-753. doi: 10.1002/bimj.201300072
[10]	Zhao JK, Li ZY, Gao Q, et al. A review of statistical methods for dietary pattern analysis[J]. Nutr J, 2021, 20(1): 37. doi: 10.1186/s12937-021-00692-7
[11]	Worley B, Powers R. PCA as a practical indicator of OPLS-DA model reliability[J]. Curr Metabolomics, 2016, 4(2): 97-103. doi: 10.2174/2213235X04666160613122429
[12]	Boccard J, Rutledge DN. A consensus orthogonal partial least squares discriminant analysis (OPLS-DA) strategy for multiblock Omics data fusion[J]. Anal Chim Acta, 2013, 769: 30-39. doi: 10.1016/j.aca.2013.01.022
[13]	Chavan RB, Thipparaboina R, Kumar D, et al. Evaluation of the inhibitory potential of HPMC, PVP and HPC polymers on nucleation and crystal growth[J]. RSC Adv, 2016, 6(81): 77569-77576. doi: 10.1039/C6RA19746A
[14]	Mašková E, Kubová K, Raimi-Abraham BT, et al. Hypromellose - A traditional pharmaceutical excipient with modern applications in oral and oromucosal drug delivery[J]. J Control Release, 2020, 324: 695-727. doi: 10.1016/j.jconrel.2020.05.045
[15]	Olechno K, Basa, Winnicka K. “success depends on your backbone” -about the use of polymers as essential materials forming orodispersible films[J]. Materials, 2021, 14(17): 4872. doi: 10.3390/ma14174872
[16]	Bharadia PD, Pandya Vikram M. A review on aqueous film coating technology[J]. Indian J Pharm Pharmacol, 2015, 1(1): 64-105.
[17]	Porter SC. 5 A proactive approach to troubleshooting the application of film coatings to oral solid dosage forms[M]//Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms. Taylor & Francis Group, CRC Press, 2016: 101-134.
[18]	Fernandes EC, Rondolfo N, Beraldo-de-Araújo V, et al. Quality deviation handling on the polymeric coating of pharmaceutical tablets[J]. J Pharm Innov, 2019, 14(4): 332-340. doi: 10.1007/s12247-018-9359-4
[19]	Kamble RS, Bakde BV, Channawar MA, et al. Enteric coated drug delivery system[J]. Res J Pharm Technol, 2013, 3(3): 665-671.
[20]	Olsson E, Hedenqvist MS, Johansson C, et al. Influence of citric acid and curing on moisture sorption, diffusion and permeability of starch films[J]. Carbohydr Polym, 2013, 94(2): 765-772. doi: 10.1016/j.carbpol.2013.02.006
[21]	Yoshida CMP, Antunes ACB, Alvear C, et al. An absorption model for the thickness effect in hydrophilic films[J]. Int J Food Sci Tech, 2005, 40(1): 41-46. doi: 10.1111/j.1365-2621.2004.00907.x
[22]	Morillon V, Debeaufort F, Blond G, et al. Factors affecting the moisture permeability of lipid-based edible films: a review[J]. Crit Rev Food Sci Nutr, 2002, 42(1): 67-89. doi: 10.1080/10408690290825466
[23]	Bajpai SK, Dehariya P, Singh Saggu SP. Investigation of moisture sorption, permeability, cytotoxicity and drug release behavior of carrageenan/poly vinyl alcohol films[J]. J Macromol Sci Part A, 2015, 52(4): 243-251. doi: 10.1080/10601325.2015.1007267
[24]	Bui TD, Wong Y, Thu K, et al. Effect of hygroscopic materials on water vapor permeation and dehumidification performance of poly(vinyl alcohol) membranes[J]. J Appl Polym Sci, 2017, 134(17): e44765. doi: 10.1002/app.44765
[25]	Ayranci E, Tunc S. The effect of fatty acid content on water vapour and carbon dioxide transmissions of cellulose-based edible films[J]. Food Chem, 2001, 72(2): 231-236. doi: 10.1016/S0308-8146(00)00227-2
[26]	Li JL, Gao JQ, Sui GZ, et al. Influence of a glycerin additive on the structure and water vapor permeance of chitosan membranes[J]. Mat Express, 2014, 4(6): 491-498. doi: 10.1166/mex.2014.1200
[27]	Espinel Villacrés RA, Flores SK, Gerschenson LN. Biopolymeric antimicrobial films: study of the influence of hydroxypropyl methylcellulose, tapioca starch and glycerol contents on physical properties[J]. Mater Sci Eng C Mater Biol Appl, 2014, 36: 108-117. doi: 10.1016/j.msec.2013.11.043
[28]	Lal SS, Tanna P, Kale S, et al. Kafirin polymer film for enteric coating on HPMC and Gelatin capsules[J]. J Mater Sci, 2017, 52(7): 3806-3820. doi: 10.1007/s10853-016-0637-6
[29]	Gungor A. Mechanical properties of iron powder filled high density polyethylene composites[J]. Mater Des, 2007, 28(3): 1027-1030. doi: 10.1016/j.matdes.2005.11.003
[30]	Maiti SN, Mahapatro PK. Mechanical properties of nickel-powder–filled polypropylene composites[J]. Polym Compos, 1992, 13(1): 47-52. doi: 10.1002/pc.750130107
[31]	Rajulu AV, Rao GB, Devi LG, et al. Tensile properties of epoxy coated natural fabric Hildegardia populifolia[J]. J Reinf Plast Compos, 2004, 23(2): 217-219. doi: 10.1177/0731684404031463
[32]	Park NY, Ko YC, Melani L, et al. Mechanical properties of low-density paper[J]. Nord Pulp Pap Res J, 2020, 35(1): 61-70. doi: 10.1515/npprj-2019-0052
[33]	Rezaee F, Ganji F. Formulation, characterization, and optimization of captopril fast-dissolving oral films[J]. AAPS PharmSciTech, 2018, 19(5): 2203-2212. doi: 10.1208/s12249-018-1027-y
[34]	Chang BK, Kim BG, Kim YJ, et al. Characterization of dexamethasone-eluting PLGA films coated on capsular tension ring to prevent posterior capsule opacification[J]. Biomol Ther, 2008, 16(4): 425-430. doi: 10.4062/biomolther.2008.16.4.425
[35]	Duda Y. Adsorption of chain molecules into a thin film structure and solvation interaction versus molecular flexibility[J]. Colloids Surf A Physicochem Eng Aspects, 2000, 161(3): 477-488. doi: 10.1016/S0927-7757(99)00211-3
[36]	Zhang QL, Zhao K, Shen XY. Metabolomic analysis reveals the adaptation in the P. przewalskii to Se-deprived environment[J]. Biol Trace Elem Res, 2022, 200(8): 3608-3620. doi: 10.1007/s12011-021-02971-0
[37]	Wold S, Esbensen K, Geladi P. Principal component analysis[J]. Chemometr Intellig Lab Sys, 1987, 2(1/2/3): 37-52. doi: 10.1016/0169-7439(87)80084-9
[38]	Huang BM, Chen TB, Xiao SY, et al. A new approach for authentication of four ginseng herbs and their related products based on the simultaneous quantification of 19 ginseng saponins by UHPLC-TOF/MS coupled with OPLS-DA[J]. RSC Adv, 2017, 7(74): 46839-46851. doi: 10.1039/C7RA06812C
[39]	Ma QD, Chen XX, Zhang K, et al. Chemical fingerprint analysis for discovering markers and identifying Saussurea involucrata by HPLC coupled with OPLS-DA[J]. J Anal Methods Chem, 2020, 2020: 7560710.
[40]	dos Santos FA, Sousa IP, Furtado NAJC, et al. Combined OPLS-DA and decision tree as a strategy to identify antimicrobial biomarkers of volatile oils analyzed by gas chromatography-mass spectrometry[J]. Rev Bras De Farmacogn, 2018, 28(6): 647-653. doi: 10.1016/j.bjp.2018.08.006
[41]	Wang HY, Yan GL, Zhang AH, et al. Rapid discovery and global characterization of chemical constituents and rats metabolites of phellodendri amurensis cortex by ultra-performance liquid chromatography-electrospray ionization/quadrupole-time-of-flight mass spectrometry coupled with pattern recognition approach[J]. Analyst, 2013, 138(11): 3303-3312. doi: 10.1039/c3an36902a
[42]	Wiklund S, Johansson E, Sjöström L, et al. Visualization of GC/TOF-MS-based metabolomics data for identification of biochemically interesting compounds using OPLS class models[J]. Anal Chem, 2008, 80(1): 115-122. doi: 10.1021/ac0713510
[43]	Galindo-Prieto B, Eriksson L, Trygg J. Variable influence on projection (VIP) for orthogonal projections to latent structures (OPLS)[J]. J Chemom, 2014, 28(8): 623-632. doi: 10.1002/cem.2627

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Correlation between critical material attributes of hydroxypropyl methyl cellulose type 2910 and film coating performance