Quality by Design (QbD)-Based Numerical and Graphical Optimization Technique for the Development of Osmotic Pump Controlled-Release Metoclopramide HCl Tablets

References

• WenH, ParkK. Oral Controlled Release Formulation Design and Drug Delivery: Theory to Practice. Wileys; 2011.
   Google Scholar
• SareenR, JainN, KumarD. An insight to osmotic drug delivery. Curr Drug Deliv. 2012;9(3):285–296. doi:10.2174/15672011280038910622452403
   PubMed Web of Science ®Google Scholar
• GuptaS, SinghRP, SharmaR, KalyanwatR, LokwaniP. Osmotic pumps: a review. Int J Comprehensive Pharm. 2011;2(6):1–8.
   Google Scholar
• TheeuwesF. Elementary osmotic pump. J Pharm Sci. 1975;64(12):1987–1991. doi:10.1002/jps.26006412181510
   PubMed Web of Science ®Google Scholar
• KeraliyaRA, PatelC, PatelP, et al. Osmotic drug delivery system as a part of modified release dosage form. ISRN Pharm. 2012;2012.
   Google Scholar
• KumarP, SinghS, MishraB. Development and evaluation of elementary osmotic pump of highly water soluble drug: tramadol hydrochloride. Curr Drug Deliv. 2009;6(1):130–139. doi:10.2174/15672010978704824919418965
   PubMedGoogle Scholar
• HarringtonR, HamiltonC, BrogdenR, LinkewichJ, RomankiewiczJ, HeelR. Metoclopramide. Drugs. 1983;25(5):451–494. doi:10.2165/00003495-198325050-000026345129
   PubMed Web of Science ®Google Scholar
• HerrstedtJ, RoilaF, WarrD, et al. 2016 Updated MASCC/ESMO consensus recommendations: prevention of nausea and vomiting following high emetic risk chemotherapy. Support Care Cancer. 2017;25(1):277–288. doi:10.1007/s00520-016-3313-027443154
   PubMed Web of Science ®Google Scholar
• Al-SaffarA, LennernäsH, HellströmPM. Gastroparesis, metoclopramide, and tardive dyskinesia: risk revisited. Neurogastroenterol Moti. 2019;31(11):e13617. doi:10.1111/nmo.13617
   PubMedGoogle Scholar
• CamilleriM, ChedidV, FordAC, et al. Gastroparesis. Nat Rev Dis Prim. 2018;4(1):41.30385743
   PubMed Web of Science ®Google Scholar
• JungHK, ChoungRS, LockeGR 3rd, et al. The incidence, prevalence, and outcomes of patients with gastroparesis in Olmsted County, Minnesota, from 1996 to 2006. Gastroenterology. 2009;136(4):1225–1233. doi:10.1053/j.gastro.2008.12.04719249393
   PubMed Web of Science ®Google Scholar
• AlbibiR, McCALLUMRW. Metoclopramide: pharmacology and clinical application. Ann Intern Med. 1983;98(1):86–95. doi:10.7326/0003-4819-98-1-866336644
   PubMed Web of Science ®Google Scholar
• PinderRM, BrogdenRN, SawyerPR, SpeightTM, AveryGS. Metoclopramide: a review of its pharmacological properties and clinical use. Drugs. 1976;12(2):81–131. doi:10.2165/00003495-197612020-00001786607
   PubMed Web of Science ®Google Scholar
• Kettaneh-WoldN. Use of experimental design in the pharmaceutical industry. J Pharm Biomed Anal. 1991;9(8):605–610. doi:10.1016/0731-7085(91)80185-C1790180
   PubMed Web of Science ®Google Scholar
• CzitromV. One-factor-at-a-time versus designed experiments. Am Stat. 1999;53(2):126–131.
   Web of Science ®Google Scholar
• PolitisN, ColomboP, ColomboGM, RekkasD. Design of experiments (DoE) in pharmaceutical development. Drug Dev Ind Pharm. 2017;43(6):889–901.28166428
   PubMed Web of Science ®Google Scholar
• PatilP, UphadeK, SaudagarR. A review: osmotic drug delivery system. Pharma Sci Monitor. 2018;9:2.
   Web of Science ®Google Scholar
• XueY, YuS, WangH, et al. Design of a timed and controlled release osmotic pump system of atenolol. Drug Dev Ind Pharm. 2015;41(6):906–915. doi:10.3109/03639045.2014.91361224796273
   PubMed Web of Science ®Google Scholar
• FassihiA, KanferI. Effect of compressibility and powder flow properties on tablet weight variation. Drug Dev Ind Pharm. 1986;12(11–13):1947–1966. doi:10.3109/03639048609042619
   Web of Science ®Google Scholar
• CapeceM, HuangZ, DavéR. Insight into a novel strategy for the design of tablet formulations intended for direct compression. J Pharm Sci. 2017;106(6):1608–1617. doi:10.1016/j.xphs.2017.02.03328283431
   PubMed Web of Science ®Google Scholar
• Available from: https://www.colorcon.com/products-formulation/all-products/film-coatings/sustained-release/opadry-ca. Accessed 112, 2020.
   Google Scholar
• Convention USP. The United States Pharmacopoeia USP 26-the National Formulary NF21: by Authority of the United States Pharmacopeial Convention, Inc., Meeting at Washington, D.C., April 12-16, 2000. United States Pharmacopeial Convention; 2002.
   Google Scholar
• KhanA, NaqviSB, ShoaibMH, et al. Validation and application of RP-HPLC method for the quantification of metoclopramide hydrochloride in oral formulations prepared for IVIVC studies. Pak J Pharm Sci. 2012;25(1):135–140.22186321
   PubMed Web of Science ®Google Scholar
• HamedR, AwadallahA, SunoqrotS, et al. pH-dependent solubility and dissolution behavior of carvedilol—case example of a weakly basic BCS class II drug. AAPS PharmSciTech. 2016;17(2):418–426. doi:10.1208/s12249-015-0365-226202065
   PubMed Web of Science ®Google Scholar
• LiboY, RezaF. Kinetic modeling on drug release from controlled drug delivery system. J Pharm Sci. 1996;85:170.8683443
   PubMed Web of Science ®Google Scholar
• SchwartzJB, SimonelliAP, HiguchiWI. Drug release from wax matrices I. Analysis of data with first‐order kinetics and with the diffusion‐controlled model. J Pharm Sci. 1968;57(2):274–277. doi:10.1002/jps.26005702065641671
   PubMed Web of Science ®Google Scholar
• HiguchiT. Mechanism of sustained‐action medication. Theoretical analysis of rate of release of solid drugs dispersed in solid matrices. J Pharm Sci. 1963;52(12):1145–1149. doi:10.1002/jps.260052121014088963
   PubMed Web of Science ®Google Scholar
• HixsonA, CrowellJ. Dependence of reaction velocity upon surface and agitation. Ind Eng Chem. 1931;23(8):923–931. doi:10.1021/ie50260a018
   Google Scholar
• KorsmeyerRW, GurnyR, DoelkerE, BuriP, PeppasNA. Mechanisms of solute release from porous hydrophilic polymers. Int J Pharm. 1983;15(1):25–35. doi:10.1016/0378-5173(83)90064-9
   Web of Science ®Google Scholar
• CostaP, LoboJMS. Modeling and comparison of dissolution profiles. Eur j Pharm Sci. 2001;13(2):123–133. doi:10.1016/S0928-0987(01)00095-111297896
   PubMed Web of Science ®Google Scholar
• SlutskyDJ. Statistical errors in clinical studies. J Wrist Surg. 2013;2(04):285–287. doi:10.1055/s-0033-135942124436830
   PubMedGoogle Scholar
• BranchSK. Guidelines from the international conference on harmonisation (ICH). J Pharm Biomed Anal. 2005;38(5):798–805. doi:10.1016/j.jpba.2005.02.03716076542
   PubMed Web of Science ®Google Scholar
• S NPC, ColomboP, ColomboG, RekkasD. Design of experiments (DoE) in pharmaceutical development. Drug Dev Ind Pharm. 2017;43(6):889–901.28166428
   PubMed Web of Science ®Google Scholar
• LiN, FanL, WuB, et al. Preparation and in vitro/in vivo evaluation of azilsartan osmotic pump tablets based on the preformulation investigation. Drug Dev Ind Pharm. 2019;1–10.30207189
   PubMed Web of Science ®Google Scholar
• VermaRK, KrishnaDM, GargS. Formulation aspects in the development of osmotically controlled oral drug delivery systems. J Controlled Release. 2002;79(1–3):7–27. doi:10.1016/S0168-3659(01)00550-8
   PubMed Web of Science ®Google Scholar
• AhmedK, ShoaibMH, YousufRI, et al. Use of Opadry® CA—a cellulose acetate/polyethylene glycol system for rate-controlled osmotic drug delivery of highly soluble antispastic agent Eperisone HCl. Adv Polym Technol. 2018;37(8):2730–2742. doi:10.1002/adv.21946
   Web of Science ®Google Scholar
• ThakkarHP, PancholiN, PatelCV. Development and evaluation of a once-daily controlled porosity osmotic pump of tapentadol hydrochloride. AAPS PharmSciTech. 2016;17(5):1248–1260. doi:10.1208/s12249-015-0463-126677859
   PubMed Web of Science ®Google Scholar
• SinchaipanidN, PongwaiS, LimsuwanP, MitrevejA. Design of salbutamol EOP tablets from pharmacokinetics parameters. Pharm Dev Technol. 2003;8(2):135–142. doi:10.1081/PDT-12001847912760564
   PubMed Web of Science ®Google Scholar
• ZentnerGM, McClellandGA, SuttonSC. Controlled porosity solubility-and resin-modulated osmotic drug delivery systems for release of diltiazem hydrochloride. J Controlled Release. 1991;16(1–2):237–243. doi:10.1016/0168-3659(91)90047-H
   Web of Science ®Google Scholar
• DevR, KumarA, PathakK. Solubility-modulated asymmetric membrane tablets of triprolidine hydrochloride: statistical optimization and evaluation. AAPS PharmSciTech. 2012;13(1):174–183. doi:10.1208/s12249-011-9738-322183255
   PubMed Web of Science ®Google Scholar
• LiuL, KhangG, RheeJM, LeeHB. Monolithic osmotic tablet system for nifedipine delivery. J Control Release. 2000;67(2–3):309–322. doi:10.1016/S0168-3659(00)00222-410825563
   PubMed Web of Science ®Google Scholar
• ZhangY, HuoM, ZhouJ, et al. DDSolver: an add-in program for modeling and comparison of drug dissolution profiles. AAPS J. 2010;12(3):263–271. doi:10.1208/s12248-010-9185-120373062
   PubMed Web of Science ®Google Scholar
• McClellandG, SuttonS, EngleK, ZentnerG. The[25] L. Yang, B. Johnson, R. Fassihi, Determination of continuous solubility-modulated osmotic pump: in vitro/in vivo release changes in the gel layer thickness of poly (ethylene oxide) of diltiazem hydrochloride. Pharm Res. 1991;8:88–92. doi:10.1023/A:10158905254952014214
   PubMed Web of Science ®Google Scholar
• BoseA, WongTW, SinghN. Formulation development and optimization of sustained release matrix tablet of Itopride HCl by response surface methodology and its evaluation of release kinetics. Saudi Pharm J. 2013;21(2):201–213. doi:10.1016/j.jsps.2012.03.00623960836
   PubMed Web of Science ®Google Scholar
• GuanJ, ZhouL, NieS, YanT, TangX, PanW. A novel gastric-resident osmotic pump tablet. 2010.
   Google Scholar
• PolliJE, RekhiGS, AugsburgerLL, ShahVP. Methods to compare dissolution profiles and a rationale for wide dissolution specifications for metoprolol tartrate tablets. J Pharm Sci. 1997;86(6):690–700. doi:10.1021/js960473x9188051
   PubMed Web of Science ®Google Scholar