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Research Article

Multivariate analysis as a method to understand variability in a complex excipient, and its contribution to formulation performance

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Pages 1146-1155 | Received 27 Mar 2018, Accepted 04 Oct 2018, Published online: 14 Nov 2018

References

  • Afrasiabi Garekani H, Dolatabadi R, Akhgari A, Abbaspour MR, Sadeghi F. 2017. Evaluation of ethylcellulose and its pseudolatex (Surelease) in preparation of matrix pellets of theophylline using extrusion-spheronization. Iran J Basic Med Sci. 20:9–16.
  • Cao QR, Choi JS, Liu Y, Xu WJ, Yang M, Lee BJ, Cui JH. 2013. A formulation approach for development of HPMC-based sustained release tablets for tolterodine tartrate with a low release variation. Drug Dev Ind Pharm. 39:1720–1730.
  • Cook G, Cai C. 2018. Chapter 19 – Multivariate analysis and the pharmaceutical regulatory framework. In: Ferreira AP, Menezes JC, Tobyn M, editors. Multivariate analysis in the pharmaceutical industry. Cambridge (MA):Academic Press; p. 421–434.
  • Corredor C. 2016. The PATability of excipients. In: Koo OY, editor. Pharmaceutical excipients: properties, functionality, and applications in research and industry. Hoboken (NJ): John Wiley and Sons; p. 303–327.
  • Costa P, Sousa Lobo JM. 2001. Modeling and comparison of dissolution profiles. Eur J Pharm Sci. 13:123–133.
  • Dave VS, Saoji SD, Raut NA, Haware RV. 2015. Excipient variability and its impact on dosage form functionality. J Pharm Sci. 104:906–915.
  • DeVos F. 2016. Risk Assessment for Excipient GMP. APV/IPEC Europe Excipient Conference 2016 – an update on regulatory and application developments; September 2016; Prague.
  • Esbensen KH, Geladi P. 2010. Principal component analysis: concept, geometrical interpretation, mathematical background, algorithms, history, practice. Compr Chemometr. 2:211–226.
  • European Commission. 2015. Guidelines of 19th March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacture practice for excipients of medicinal products for human use. OJEU.
  • FDA. 1997. FDA guidance for industry, dissolution testing of immediate release solid oral dosage forms. https://www.fda.gov/downloads/drugs/guidances/ucm070237.pdf
  • Ferreira AP, Tobyn M. 2015. Multivariate analysis in the pharmaceutical industry: enabling process understanding and improvement in the PAT and QbD era. Pharm Dev Technol. 20:513–527.
  • Gamble JF, Chiu WS, Gray V, Toale H, Tobyn M, Wu Y. 2010. Investigation into the degree of variability in the solid-state properties of common pharmaceutical excipients-anhydrous lactose. AAPS PharmSciTech. 11:1552–1557.
  • Garekani HA, Ahmadi B, Sadeghi F. 2017. Effect of variation in viscosity grade of ethycellulose on theophylline microcapsule properties prepared by emulsion solvent evaporation. Curr Drug Deliv. 14:73–82.
  • Geladi P, Grahn H. 2018. Chapter 2 – The philosophy and fundamentals of handling, modeling, and interpreting large data sets—the multivariate chemometrics approach. In: Ferreira AP, Menezes JC, Tobyn M, editors. Multivariate analysis in the pharmaceutical industry. Cambridge (MA):Academic Press; p. 13–34.
  • Hertrampf A, Müller H, Menezes JC, Herdling T. 2015. Advanced qualification of pharmaceutical excipient suppliers by multiple analytics and multivariate analysis combined. Int J Pharm. 495:447–458.
  • IPEC. 2015. IPEC Europe "how to" document. Guidelnes of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use. IPEC. http://ipec-europe.org/UPLOADS/160318_IE_How-to_do_RAGuidelines_v1_2.pdf
  • Jagadeesh T, Chary BRR. 2011. Development of oral multi particulate drug delivery system of galantamine hydrobromide by using extrusion spheronization technique. Int J Pharm Technol. 3:2633–2643.
  • Kazlauske J, Cafaro MM, Caccavo D, Marucci M, Lamberti G, Barba AA, Larsson A. 2017. Determination of the release mechanism of theophylline from pellets coated with Surelease®—A water dispersion of ethyl cellulose. Int J Pharm. 528:345–353.
  • Kubova K, Peček D, Hasserová K, Doležel P, Pavelková M, Vyslouzil J, Muselík J, Vetchy D. 2017. The influence of thermal treatment and type of insoluble poly(meth)acrylates on dissolution behavior of very soluble drug from hypromellose matrix tablets evaluated by multivariate data analysis. Pharm Dev Technol. 22:206–217.
  • Kushner J. 2013. Utilizing quantitative certificate of analysis data to assess the amount of excipient lot-to-lot variability sampled during drug product development. Pharm Dev Technol. 18:333–342.
  • Kushner J, Langdon BA, Hicks I, Song D, Li F, Kathiria L, Kane A, Ranade G, Agarwal K. 2014. A quality-by-design study for an immediate-release tablet platform: examining the relative impact of active pharmaceutical ingredient properties, processing methods, and excipient variability on drug product quality attributes. J Pharm Sci. 103:527–538.
  • Leng DE, Mossbach W, Sigelko WL, Sounders FL, Uirumaa RS. inventor 1985. Aqueous dispersions of plasticized polymer particles. patent US4,502,888
  • Leng DE, Warner GL. inventor 1977. Continuous process for preparing aqueous polymer microsuspensions. patent 4,123, 403A.
  • Mehta R, Teckoe J, Schoener C, Workentine S, Ferrizzi D, Rajabi-Siahboomi A. 2016. Investigation into the effect of ethylcellulose viscosity variation on the drug release of metoprolol tartrate and acetaminophen extended release multiparticulates-Part I. AAPS Pharm Sci Tech. 17:1366–1375.
  • Melegari C, Bertoni S, Genovesi A, Hughes K, Rajabi-Siahboomi AR, Passerini N, Albertini B. 2016. Ethylcellulose film coating of guaifenesin-loaded pellets: a comprehensive evaluation of the manufacturing process to prevent drug migration. Eur J Pharm Biopharm. 100:15–26.
  • Mercuri A, Pagliari M, Baxevanis F, Fares R, Fotaki N. 2017. Understanding and predicting the impact of critical dissolution variables for nifedipine immediate release capsules by multivariate data analysis. Int J Pharm. 518:41–49.
  • Mohammadpour M, Kerins B, Crowely ME, Walker GW, Crean AM. 2016. HPMC cloud point: Exploring hydroxypropylmethyl cellulose behavior in pharmaceutical formulations. Food, Pharmaceutical and Bioengineering Division 2016 – Core Programming Area at the 2016 AIChE Annual Meeting; San Francisco; 13–18 November. p. 1027–1030.
  • Moreton RC. 2016. Managing excipients for Quality-by-Design projects. Chimica Oggi/Chem Today. 34:53–55.
  • Mustafa ME, Nur AO, Osman ZA, Ahmed SA. 2014. Influence of drug solubility and polymers supply source on the physical performance of matrix tablets. Int J Pharm Pharmaceut Sci. 6:308–312.
  • Narang AS. 2015. Addressing excipient variability in formulation design and drug development. In: Narang AS, Boddu SHS, editors. Excipient applications in formulation design and drug delivery. Switzerland: Springer; p. 541–567.
  • Narang AS, Mantri RV, Raghavan KS. 2016. Excipient compatibility and functionality. In: Qiu Y, Chen Y, Zhang G, Yu L, Mantri RV, editors. Developing solid oral dosage forms: pharmaceutical theory and practice. 2nd ed. Cambridge (MA): Academic Press; p. 151–179.
  • Paixão P, Gouveia LF, Silva N, Morais JAG. 2017. Evaluation of dissolution profile similarity – comparison between the f2, the multivariate statistical distance and the f2 bootstrapping methods. Eur J Pharm Biopharm. 112:67–74.
  • Parikh NH, Porter SC, Rohera BD. 1993a. Aqueous ethylcellulose dispersion of ethylcellulose I. evaluation of coating process variables. AAPS Pharm Res. 10:525–534.
  • Parikh NH, Porter SC, Rohera BD. 1993b. Tensile properties of free films cast from aqueous ethylcellulose dispersions. AAPS Pharm Res. 10:810–815.
  • Patil V, Belsare D. 2017. Development and evaluation of novel drug delivery system of tolterodine tartrate. Int J App Pharm. 9:29–32.
  • Paul Y, Tyagi S, Singh B. 2011. Formulation and evaluation of taste masked dispersible tablets of zidovudine. Int J Pharm Bio Sci. 2:20–30.
  • Polli JE, Rekhi GS, Augsburger LL, Shah VP. 1997. Methods to compare dissolution profiles and a rationale for wide dissolution specifications for metoprolol tartrate tablets. J Pharm Sci. 86:690–700.
  • Rajabi-Siahboomi A, Mehta RY, Dias V, Tiwari SB. 2017a. Ethylcellulose applications in multiparticulate systems. In: Rajabi-Siahboomi A, editor. Multiparticulate drug delivery systems: formulation, processing and manufacturing. New York: Springer.
  • Rajabi-Siahboomi A, Mehta R, Dias V, Tiwari S. 2017b. The application of formulated systems for the aqueous film coating of pharmaceutical oral solid dosage forms. In: Felton L, editor. Aqueous polymeric coatings for pharmaceutical dosage forms (4th Edition). London (UK): CRC Press (Taylor and Francis).
  • Sathe PM, Tsong Y, Shah VP. 1996. In-vitro dissolution profile comparison: statistics and analysis, model dependent approach. Pharm Res. 13:1799–1803.
  • Soh JLP, Liew CV, Heng PWS. 2015. Impact of excipient variability on drug product processing and performance. CPD. 21:5890–5899.
  • Tang L, Schwartz JB, Porter SC, Schnaare RL, Wigent RJ. 2000. Drug release from film-coated chlorpheniramine maleate nonpareil beads: effect of water-soluble polymer, coating level, and soluble core material. Pharm Dev Technol. 5:383–390.
  • Tayade N, Baweja J, Rajabi-Siahboomi A. 2016. Critical quality attributes of sugar spheres as multiparticulate seeds – more than the monograph. Pharma Times. 48:33–36.
  • Thoorens G, Krier F, Leclercq B, Carlin B, Evrard B. 2014. Microcrystalline cellulose, a direct compression binder in a quality by design environment – a review. Int J Pharm. 473:64–72.
  • Thoorens G, Krier F, Rozet E, Carlin B, Evrard B. 2015. Understanding the impact of microcrystalline cellulose physicochemical properties on tabletability. Int J Pharm. 490:47–54.
  • Tobyn M, Ferreira AP, Morris C, Menezes JC. 2018. The preeminence of multivariate data analysis as a statistical data analysis technique in pharmaceutical and manufacturing. In: Ferreira AP, Menezes JC, Tobyn M, editors. Multivariate analysis in the pharmaceutical industry. Cambridge (MA):Academic Press; p. 3–12.
  • Viridén A, Abrahmsén-Alami S, Wittgren B, Larsson A. 2011. Release of theophylline and carbamazepine from matrix tablets-consequences of HPMC chemical heterogeneity. Eur J Pharm Biopharm. 78:470–479.
  • Viridén A, Wittgren B, Larsson A. 2011. The consequence of the chemical composition of HPMC in matrix tablets on the release behaviour of model drug substances having different solubility. Eur J Pharm Biopharm. 77:99–110.
  • Vonica AL, Tomuţǎ I, Leucuţa SE. 2011. Experimental design for the screening of three types of coating polymers for metoprolol minitablets with pulsatile release. Farmacia. 59:742–749.
  • Yin LF, Huang SJ, Jiang SG, Zhao CJ, Pei ZQ, Zhang Q. 2011. In vitro and in vivo evaluation of levofloxacin sustained-release capsules. Drug Dev Ind Pharm. 37:33–40.
  • Zarmpi P, Flanagan T, Meehan E, Mann J, Fotaki N. 2017. Biopharmaceutical aspects and implications of excipient variability in drug product performance. Eur J Pharm Biopharm. 111:1–15.
  • Zhang F. 2016. Physicochemical properties and mechanisms of drug release from melt-extruded granules consisting of chlorpheniramine maleate and Eudragit FS. Drug Dev Ind Pharm. 42:563–571.

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