QbD for pediatric oral lyophilisates development: risk assessment followed by screening and optimization

References

• Salunke S, Hempenstall J, Kendall R, et al. European Paediatric Formulation Initiative’s (EuPFI) 2nd conference commentary- Formulating better medicine for children. Int J Pharm. 2011;419:235–239.
   PubMed Web of Science ®Google Scholar
• World Health Organization. Development of Paediatric Medicines: Points to Consider in Pharmaceutical Development. Working document QAS/08.257/Rev.3; 2011.
   Google Scholar
• EMA. Guideline on pharmaceutical development of medicines for paediatric use. 2013 [cited 2016 June 7]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/07/WC500147002.pdf
   Google Scholar
• Lopez FL, Ernest TB, Tuleu C, et al. Formulation approaches to pediatric oral drug delivery: benefits and limitations of current platforms. Expert Opin Drug Deliv. 2015;12:1727–1740.
   PubMed Web of Science ®Google Scholar
• Fields J, Go JT, Schulze KS. Pill properties that cause dysphagia and treatment failure. Curr Ther Res Clin Exp. 2015;77:79–82.
   PubMed Web of Science ®Google Scholar
• European Directorate for the Quality of Medicines (EDQM) European Pharmacopoeia. 8th ed. Strasbourg, France: Council of Europe; 2014.
   Google Scholar
• Sam T, Ernest TB, Walsh J, et al. A benefit/risk approach towards selecting appropriate pharmaceutical dosage forms-an application for paediatric dosage form selection. Int J Pharm. 2012;435:115–123.
   PubMed Web of Science ®Google Scholar
• Guidance for Industry. Q8(R2) Pharmaceutical Development. 2009 [cited 2016 August 9]. Available from: http://www.fda.gov/downloads/Drugs/./Guidances/ucm073507.pdf
   Google Scholar
• Guidance for Industry Q9 Quality Risk Management. 2006 [cited 2016 October 18]. Available from: http://www.fda.gov/cder/guidance/index.htm.
   Google Scholar
• Eriksson L, Byrne T, Johansson E, et al. Multi- and megavariate data analysis: basic principles and applications. 3rd ed. Malmo: MKS Umetrics AB; 2013.
   Google Scholar
• Kaljevic O, Djuris J, Djuric Z, et al. Application of failure mode and effects analysis approach for formulation of carvedilol compression coated tablets. J Drug Deliv Sci Technol. 2016;32:56–63.
   Web of Science ®Google Scholar
• Vora C, Patadia R, Mittal K, et al. Risk based approach for design and optimization of stomach specific delivery of rifampicin. Int J Pharm. 2013;455:169–181.
   PubMed Web of Science ®Google Scholar
• Eriksson L, Johansson E, Kettaneh-Wold N, et al. Design of experiments principles and applications. 3rd ed. Sweden: Umetrics; 2008.
   Google Scholar
• Aguiar PF, Bourguigon B, Khots MS, et al. Tutorial D-optimal designs. Chem Int Lab Syst. 1995;30:199–210.
   Web of Science ®Google Scholar
• Iurian S, Tomuta I, Bogdan C, et al. Defining the design space for freeze-dried orodispersible tablets with meloxicam. Drug Dev Ind Pharm. 2016;42:1977–1989.
   PubMed Web of Science ®Google Scholar
• Geidobler R, Winter G. Controlled ice nucleation in the field of freeze-drying: Fundamentals and technology review. Eur J Pharm Biopharm. 2013;85:214–222.
   PubMed Web of Science ®Google Scholar
• Searles JA, Carpenter JF, Randolph TW. Annealing to optimize the primary drying rate, reduce freezing-induced drying rate heterogeneity, and determine Tg’ in pharmaceutical lyophilization. J Pharm Sci. 2001;90:872–887.
   PubMed Web of Science ®Google Scholar
• Pikal MJ, Shah S. The collapse temperature in freeze drying: Dependence on measurement methodology and rate of water removal from the glassy phase. Int J Pharm. 1990;62:165–186.
   Web of Science ®Google Scholar
• Li H, Tan Y, Yang L, et al. Dissolution evaluation in vitro and bioavailability in vivo of self-microemulsifying drug delivery systems for pH-sensitive drug loratadine. J Microencapsul. 2015;32:175–180.
   PubMed Web of Science ®Google Scholar
• Tang XC, Pikal MJ. Design of freeze-drying processes for pharmaceuticals: practical advices. Pharm Res. 2004;21:191–200.
   PubMed Web of Science ®Google Scholar
• Schwegman J. Using differential scanning calorimetry (DSC) for Optimized Lyophilization Cycle Design, SP Sci. Techcnical Notes - LyoLearn Tech Briefs. 2011;1–6.
   Google Scholar
• U.S. Department of Health and Human Services Food and Drug Administration. Guidance for Industry Orally Disintegrating Tablets. [Online] 2008. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070578.pdf
   Google Scholar
• Kocherbitov V, Ulvenlund S, Briggner LE, et al. Hydration of natural polyelectrolyte xanthan gum: comparison with non-ionic carbohydrates. Carbohydrate Polym. 2010;82:284–290.
   Web of Science ®Google Scholar
• Bueno VB, Bentini R, Catalani LH, et al. Synthesis and swelling behavior of xanthan-based hydrogels. Carbohydr Polym. 2013;92:1091–1099.
   PubMed Web of Science ®Google Scholar
• Tavassoli-Kafrani E, Shekarchizadeh H, Masodpour-Behabadi M. Development of edible films and coatings from alginates and carrageenans. Carbohydr Polym. 2016;137:360–374.
   PubMed Web of Science ®Google Scholar
• Rowe R, Sheskey P, Quinn M. Handbook of Pharmaceutical Excipients. 6th ed. Chicago (IL): Pharmaceutical Press; 2009.
   Google Scholar
• Chandrasekhar R, Hassan Z, AlHusban F, et al. The role of formulation excipients in the development of lyophilised fast-disintegrating tablets. Eur J Pharm Biopharm. 2009;72:119–129.
   PubMed Web of Science ®Google Scholar
• AlHusban F, Perrie Y, Mohammed AR. Preparation, optimization and characterization of lyophilised rapid disintegrating tablets based on gelatin and a saccharide. Cdd. 2010;7:119–129.
   Google Scholar
• Stange U, Fuhrling C, Gieseler H. Influence of non-water_soluble placebo pellets of different sizes on the characteristics of orally disintegrating tablets manufactured by freeze drying. J Pharm Sci. 2013;102:1786–1799.
   PubMed Web of Science ®Google Scholar
• Chen YD, Liang ZY, cen YY, et al. Development of oral dispersible tablets containing prednisolone nanoparticles for the management of pediatric asthma. Drug Des Devel Ther. 2015;9:5815–5825.
   PubMedGoogle Scholar
• Labib GS. Novel levocetirizine HCl tablets with enhanced palatability: synergistic effect of combining taste modifiers and effervescence technique. Drug Des Devel Ther. 2015;9:5135–5146.
   PubMed Web of Science ®Google Scholar
• Iurian S, Tomuţă I, Leucuţa SE. Formulation of orodispersible tablets containing meloxicam and their in vitro and in vivo characterization. Farmacia. 2014;62:1097–1108.
   Web of Science ®Google Scholar