Pharmaceutical suspensions of ursodeoxycholic acid for pediatric patients: in vitro and in vivo studies

References

• Ali H, Saad R, Ahmed A, El-Haj B. 2016. Extemporaneous furosemide suspensions for pediatrics use prepared from commercially available tablets. Int J Pharm Pharm Res. 5:116–138.
   Google Scholar
• Allergan. 2014. “URSO”and “URDO DS” tablets. Canada: Aptalis Pharma Canada Inc; [Accessed April 25, 2020]. https://allergan-web-cdnprod.azureedge.net/allergancanadaspecialty/allergancanadaspecialty/media/actavis-canada-specialty/en/products/pms/urso_urso-ds-pm_english_18aug2014.pdf.
   Google Scholar
• Anand V, Kharb V, Kataria M, Kukka V, Choudhury PK. 2008. Taste assessment trials for sensory analysis of oral pharmaceutical products. Pak J Pharm Sci. 21:438–450.
   PubMed Web of Science ®Google Scholar
• Batchelor HK, Marriott JF. 2015. Formulations for children: problems and solutions. Br J Clin Pharmacol. 79:405–418.
   PubMed Web of Science ®Google Scholar
• Blasques Bueno V, Freitas Siqueira Petri D. 2014. Xanthan hydrogel films: molecular conformation, charge density and protein carriers. Carbohydr Polym. 101:897–904.
   PubMed Web of Science ®Google Scholar
• Boscolo O, Flor S, Dobrecky C, Martinefski M, Tripodi V, Lucangioli S. 2018. LC-MS/MS method applied to the detection and quantification of ursodeoxycholic acid related substances in raw material and pharmaceutical formulation. J Pharm Pharmacol. 6:448–455.
   Google Scholar
• Boscolo O, Flor S, Dobrecky C, Salvo L, Tripodi V, Lucangioli S. 2017. Development and validation of a LC-UV method applied to the quality control of ursodeoxycholic acid in raw material and pharmaceutical formulations. IOSRPHR. 07 :1:111–116.
   Google Scholar
• European Medicines Agency (EMA). 2017. Benzyl alcohol and benzoic acid group used as excipients. (EMA/CHMP/508188/2013). [accessed 2020 May 18]. https://www.ema.europa.eu/en/benzyl-alcohol
   Google Scholar
• Estevez P, Boscolo O, Quiroga E, Fernandez Penuto R, Buontempo F, Tripodi V, Lucangioli S. 2016. Development and stability study of glibenclamide oral liquid paediatric formulations for the treatment of permanent neonatal diabetes mellitus. Eur J Hosp Pharm. 23:213–216.
   PubMedGoogle Scholar
• European Pharmacopoeia. 2008. 2008 European Pharmacopoeia 6.0. Ursodeoxycholic Acid. 1275:3168–3169.
   Google Scholar
• European Pharmacopoeia. 2011. 2011 European Pharmacopoeia 7.0. Methods of Analysis. 2.9.40. Uniformity of Dosage Units.
   Google Scholar
• Geiger CM, Voudrie MA, Sorenson B. 2012. Stability of ursodiol in SyrSpend SF Cherry flavored. Int J Pharm Compd. 16:510–512.
   PubMedGoogle Scholar
• Graham S, Turner M. 2011. European Study of Neonatal Exposure to Excipients (ESNEE). Infant 7:196–199.
   Google Scholar
• Grupo Biotoscana. 2020. Ursofalk suspension oral 250 mg/5 ml. [Accessed May 18] https://www.grupobiotoscana.com/es/pais_chile/ursofalk-suspension-oral-250-mg-5-ml/.
   Google Scholar
• Hempfling W, Dilger K, Beuers U. 2003. Systematic review: ursodeoxycholic acid-adverse effects and drug interactions. Aliment Pharmacol Ther. 18:963–972.
   PubMed Web of Science ®Google Scholar
• Hippalgaonkar K, Majumdar S, Kansara V. 2010. Injectable lipid emulsions-advancements, opportunities and challenges. AAPS PharmSciTech. 11:1526–1540.
   PubMed Web of Science ®Google Scholar
• ICH. 2003. International Conference on Harmonisation of Technical Requeriments for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline. Stability Testing of New Drug Substances and Products Q1A(R2) step.
   Google Scholar
• Jadhav KR, Sankpal SV, Sawant SV, Kadam VJ. 2012. Development and in vitro evaluation of film coated micronized immediate release tablets of ursodeoxycholic acid. Der Pharm Lett. 4 :714–719.
   Google Scholar
• Johnson CE, Streetman DD. 2002. Stability of oral suspensions of ursodiol made from tablets. Am J Health Syst Pharm. 59:361–363.
   PubMed Web of Science ®Google Scholar
• Li G, Xu J, Zhang J, Zhang Z, Xiao H, Li X. 2014. Combination of submicroemulsion and phospholipid complex for novel delivery of ursodeoxycholic acid. Pharm Dev Technol. 7450:363–372.
   Google Scholar
• Lindor KD, Bowlus CL, Boyer J, Levy C, Mayo M. 2019. Primary biliary cholangitis: 2018 practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 69:394–419.
   PubMed Web of Science ®Google Scholar
• Lucangioli SE, Carducci CN, Tripodi VP, Kenndler E. 2001. Retention of bile salts in micellar electrokinetic chromatography: relation of capacity factor to octanol-water partition coefficient and critical micellar concentration. J Chromatogr B. 765:113–120.
   PubMed Web of Science ®Google Scholar
• Mallett MS, Hagan RL, Peters DA. 1997. Stability of ursodiol 25 mg/mL in an extemporaneously prepared oral liquid. Am J Health Syst Pharm. 54:1401–1404.
   PubMed Web of Science ®Google Scholar
• Martinefski M, Contin M, Rodriguez M, Geréz E, Galleano M, Lucangioli S, Bianciotti L, Tripodi V. 2014. Coenzyme Q in pregnant women and rats with intrahepatic cholestasis. Liver Int. 34:1040–1048.
   PubMed Web of Science ®Google Scholar
• Melchor-Mendoza YK, Martínez-Benítez B, Mina-Hawat A, Rodríguez-Leal G, Duque X, Moran-Villota S. 2017. Ursodeoxycholic acid therapy in patients with primary biliary cholangitis with limited liver transplantation availability. J Mexican Assoc Hepatol. 16:430–435.
   Web of Science ®Google Scholar
• Moghimipour E, Salimi A, Rezaee S, Balack M. 2014. Influence of flocculating agents and structural vehicles on the physical stability and rheological behavior of nitrofurantoin suspension. Jundishapur. J Nat Pharm Prod. 9:1–6.
   PubMedGoogle Scholar
• Mueller S, Llewellin EW, Mader HM. 2010. The rheology of suspensions of solid particles. Proc R Soc A. 466:1201–1228.
   Google Scholar
• Nunn T, Williams J. 2005. Formulation of medicines for children. Br J Clin Pharmacol. 59:674–676.
   PubMed Web of Science ®Google Scholar
• Patel VP, Desai TR, Chavda BG, Katira RM. 2011. Extemporaneous dosage form for oral liquids. Pharmacophore. 2:86–103.
   Google Scholar
• Pawar S, Kumar A. 2002. Issues in the formulation of drugs for oral use in children: role of excipients. Paediatr Drugs. 4:371–379.
   PubMedGoogle Scholar
• Pramar YV, Mandal TK, Bostanian LA, Nguyen AT, Miller V, Morris TC, Graves RA. 2019. Stability of compounded ursodiol suspensions in PCCA Base, SuspendIt. Int J Pharm Compd. 23:70–76.
   PubMedGoogle Scholar
• Remington. 2011. The science and practice of pharmacy. 21st ed. Philadelphia (PA): Lippincott Wlliams & Wilkins.
   Google Scholar
• Roda A, Gatti R, Cavrini V, Cerrè C, Simoni P. 1993. HPLC study of the impurities present in different ursodeoxycholic acid preparations: comparative evaluation of four detectors. J Pharm Biomed Anal. 11:751–760.
   PubMed Web of Science ®Google Scholar
• Ross-Murphy SB. 1994. Physical techniques for the study of food biopolymers. Rheological methods. London (UK): Blackie Academic & Professional, Chapman & Hall. p. 343–393.
   Google Scholar
• Rowe RC, Sheskey PJ, Quinn ME. 2009a. Handbook of pharmaceutical excipients. 6th ed. London (UK): Pharmaceutical Press. p. 385–387.
   Google Scholar
• Rowe RC, Sheskey PJ, Quinn ME. 2009b. Handbook of pharmaceutical excipients. 6th ed. London (UK): Pharmaceutical Press. p. 608–610.
   Google Scholar
• Salazar de Saavedra M, Saavedra Cuadra II. 2000. Application of a sensorial response model to the design of an oral liquid pharmaceutical dosage form. Drug Dev Ind Pharm. 26:55–60.
   PubMed Web of Science ®Google Scholar
• Santoveña A, Sánchez E, Charola L, Llabrés M, Fariña JB. 2014. Study of quality and stability of ursodeoxycholic acid formulations for oral pediatric administration. Int J Pharm. 477:32–38.
   PubMed Web of Science ®Google Scholar
• Setchell KD, Galzigna L, O'Connell N, Brunetti G, Tauschel HD. 2005. Bioequivalence of a new liquid formulation of ursodeoxycholic acid (Ursofalk suspension) and Ursofalk capsules measured by plasma pharmacokinetics and biliary enrichment. Aliment Pharmacol Ther. 21:709–721.
   PubMed Web of Science ®Google Scholar
• Shchipunov YA, Koneva E, Postnova I. 2002. Homogeneous alginate gels: phase behavior and rheological properties. Polym Sci Series A. 44:758–766.
   Web of Science ®Google Scholar
• Steffe JF. 1996. Rheological methods in food process engineering. 2nd ed. East Lansing (MI): Freeman Press.
   Google Scholar
• The National Academies. 2011. Guide for the care and use of laboratory animals, 8th edn. Washington DC: National Academies Press; [accessed 2020 May, 15]. https://grants.nih.gov/grants/olaw/guide-for-the-care-and-use-of-laboratory-animals.pdf/.
   Google Scholar
• Tran PH, Tran TT, Lee K, Kim D, Lee B. 2010. Dissolution-modulating mechanism of pH modifiers in solid dispersion containing weakly acidic or basic drugs with poor water solubility. Expert Opin Drug Deliv. 7:647–666.
   PubMed Web of Science ®Google Scholar
• United States Pharmacopeia. 2008. 2008 USP 31 NF 26. Microbial Limit Test. 76–80.
   Google Scholar
• United States Pharmacopeia. 2017. 2017 USP 40. Official Monographs Ursodiol. 6628–6630.
   Google Scholar
• United States Pharmacopeia. 2018. 2018 USP 40. (905) Uniformity of dosage units. 2–5.
   Google Scholar
• United States Pharmacopeia. 2019. 2019 USP 40. (795) pharmaceutical compounding – nonsterile preparations.
   Google Scholar
• Yuan H, Xie H, Xiao X, Yang M, Liao M, Zhu W. 2008. Preparation, characterization, and bioavailability of ursodeoxycholic acid – phospholipid complex in vivo. Drug Dev Ind Pharm. 34:708–718.
   PubMed Web of Science ®Google Scholar
• Zhong L, Oostrom M, Truex MJ, Vermeul VR, Szecsody JE. 2013. Rheological behavior of xanthan gum solution related to shear thinning fluid delivery for subsurface remediation. J Hazard Mater. 244-245:160–170.
   PubMed Web of Science ®Google Scholar