References
- Zaid AN. Attitude and perception of patients and health care practitioners toward oral sustained release dosage forms in Palestine. Saudi Pharm J. 2010;18:251–256.
- Verstraete G, Van RJ, Van Bockstal PJ. Hydrophilic thermoplastic polyurethanes for the manufacturing of highly dosed oral sustained release matrices via hot melt extrusion and injection molding. Int J Pharm. 2016;506:214–221.
- Laurora I, Wang Y. Pharmacokinetic profile of extended-release versus immediate-release oral naproxen sodium after single and multiple dosing under fed and fasting conditions: two randomized, open-label trials. CP. 2016;54:750.
- Flicker F, Betz G. Effect of crospovidone and hydroxypropyl cellulose on carbamazepine in high-dose tablet formulation. Drug Dev Ind Pharm. 2012; 38:697–705.
- Teller RS, Malaspina DC, Rastogi R, et al. Controlling the hydration rate of a hydrophilic matrix in the core of an intravaginal ring determines antiretroviral release. J Control Release. 2016;224:176–183.
- Vanhoorne V, Vanbillemont B, Vercruysse J, et al. Development of a controlled release formulation by continuous twin screw granulation: influence of process and formulation parameters. Int J Pharm. 2016;505:61–68.
- Moreton C. Functionality and performance of excipients in a quality-by design world, part 4: obtaining information on excipient variability for formulation design space. Am Pharm Rev. 2009;12:28–33.
- International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Quality Guideline Q8 Pharmaceutical Development Q8. Center for Drug Evaluation and Research; 2006.
- U.S. Food Drug Administration. Pharmaceutical cGMPs for the 21st century. Rockville: U.S. Food Drug Administration; 2004.
- Tomba E, Facco P, Bezzo F, et al. Latent variable modeling to assist the implementation of Quality-by-Design paradigms in pharmaceutical development and manufacturing: a review. Int J Pharm. 2013;457:283–297.
- Lawrence XY. Pharmaceutical quality by design: product and process development, understanding, and control. Pharm Res. 2008;25:781–791.
- Viridén A, Larsson A, Schagerlöf H, et al. Model drug release from matrix tablets composed of HPMC with different substituent heterogeneity. Int J Pharm. 2010;401:60–67.
- Piriyaprasarth S, Sriamornsak P. Effect of source variation on drug release from HPMC tablets: linear regression modeling for prediction of drug release. Int J Pharm. 2011;411:36–42.
- Zhou D, Law D, Reynolds J, et al. Understanding and managing the impact of HPMC variability on drug release from controlled release formulations. J Pharm Sci. 2014;103:1664–1672.
- Talukdar MM, Michoel A, Rombaut P, et al. Comparative study on xanthan gum and hydroxypropylmethyl cellulose as matrices for controlled-release drug delivery I. Compaction and in vitro drug release behaviour. Int J Pharm. 1996;129:233–241.
- Reynolds TD, Mitchell SA, Balwinski KM. Investigation of the effect of tablet surface area/volume on drug release from hydroxypropylmethylcellulose controlled-release matrix tablets. Drug Dev Ind Pharm. 2002;28:457–466.
- Jain AK, Söderlind E, Viridén A, et al. The influence of hydroxypropyl methylcellulose (HPMC) molecular weight, concentration and effect of food on in vivo erosion behavior of HPMC matrix tablets. J Control Release 2014;187:50–58.
- Bettini R, Catellani PL, Santi P, et al. Translocation of drug particles in HPMC matrix gel layer: effect of drug solubility and influence on release rate. J Control Release. 2001;70:383–391.
- Hiremath PS, Saha RN. Oral controlled release formulations of rifampicin. Part II: effect of formulation variables and process parameters on in vitro release. Drug Deliv. 2008;15:159–168.
- Duchesne C, Macgregor JF. Establishing multivariate specification regions for incoming materials. J Qual Technol. 2004;36:78–94.
- García-Muñoz S. Establishing multivariate specifications for incoming materials using data from multiple scales. Chemometr Intell Lab. 2009; 98:51–57.
- Pérez NF, Boqué R, Ferré J. Establishment of multivariate specifications for food commodities with discriminant partial least squares. Talanta. 2010;83:475–481.
- Azari K, Lauzon-Gauthier J, Tessier J, et al. Establishing multivariate specification regions for raw materials using SMB-PLS. IFAC-PapersOnLine. 2015;48:1132–1137.
- Macgregor JF, Liu Z, Bruwer MJ, et al. Setting simultaneous specifications on multiple raw materials to ensure product quality and minimize risk. Chemometr Intell Lab. 2016;157:96–103.
- Saurí J, Millán D, Suñé-Negre JM, et al. The use of the SeDeM diagram expert system for the formulation of Captopril SR matrix tablets by direct compression. Int J Pharm. 2014;461:38–45.
- Aguilar-Díaz JE, García-Montoya E, Pérez-Lozano P, et al. SeDeM expert system a new innovator tool to develop pharmaceutical forms. Drug Dev Ind Pharm. 2014;40:222–236.
- U.S. Food Drug Administration. Pharmacopeia of USA – chapter 711: dissolution. Rockville: USP; 2017.
- Dai S, Xu B, Zhang Y, et al. Robust design space development for HPLC analysis of five chemical components in Panax notoginseng saponins. J Liq Chromatogr R T. 2016;39:504–512.
- Narayan P, Hancock BC. The relationship between the particle properties, mechanical behavior, and surface roughness of some pharmaceutical excipient compacts. Mat Sci Eng A. 2003;355:24–36.
- Song M, Hammiche A, Pollock HM, et al. Modulated differential scanning calorimetry, and glass transition behaviour in poly (methyl methacrylate) and poly (epichlorohydrin) blends. Polymer 1996;37:5661–5665.
- Aulton ME. Pharmaceutics: the science of dosage form design. Edinbergh: Churchill Livingstone; 2002.
- Jallo LJ, Chen Y, Bowen J, et al. Prediction of inter-particle adhesion force from surface energy and surface roughness. J Adhes Sci Technol. 2011;25:367–384.
- Zhang Y, Che E, Zhang M, et al. Increasing the dissolution rate and oral bioavailability of the poorly water-soluble drug valsartan using novel hierarchical porous carbon monoliths. Int J Pharm. 2014;473:375–383.
- Crouter A, Briens L. The effect of moisture on the flowability of pharmaceutical excipients. Aaps Pharmscitech. 2014;15:65–74.
- Akaike H. An information criterion (AIC). Math Sci. 1976;14:5–9.
- Korsmeyer RW, Gurny R, Doelker E, et al. Mechanisms of solute release from porous hydrophilic polymers. Int J Pharm. 1983;15:25–35.
- Wold S, Sjöström M, Eriksson L. PLS-regression: a basic tool of chemometrics. Chemom Intell Lab Syst. 2001;58:109–130.
- Xu QS, Liang YZ, Shen HL. Generalized PLS regression. J Chemometrics. 2001;15:135–148.
- Donnet S. Monte Carlo simulation for the pharmaceutical industry. Int Stat Rev. 2012;80:186–187.
- Kim H, Fassihi R. A new ternary polymeric matrix system for controlled drug delivery of highly soluble drugs: I. Diltiazem hydrochloride. Pharm Res. 1997;14:1415–1421.