Advancements in Formulation Approaches to Pediatric Oral Drug Delivery systems

Year 2021, Volume: 41 Issue: 4, 254 - 265, 01.12.2021

Sanika Kole Ashwin Kuchekar , Dnyanesh Limaye

https://doi.org/10.52794/hujpharm.941321

Cited By: 2

Abstract

Designing and developing pediatric formulations is a challenging task as different patients have varied needs. Drug administration, flexibility, patient compliance, palatability, toxicity are the factors that are required to be considered during the development of pediatric preparations. To overcome the drawbacks of conventional drug delivery systems, the researchers have focused on various innovative methods such as novel drug delivery systems (NDDS). NDDS focuses on the formulation and development of pediatric formulations considering tolerability, efficacy and safety of active pharmaceutical ingredients and excipients.

Keywords

Pediatrics, Palptability, Formulation, Oral drug delivery system, Novel drug delivery system

Pediatrik Oral İlaç Salım sistemlerine Formülasyon Yaklaşımlarındaki Gelişmeler

Abstract

Keywords

Pediatri, Lezzet, Formülasyon, Oral ilaç verilmesi, Yeni ilaç dağıtım sistemi

References

• 1. Lozep, F., Ernest, T., Tuleu, C. Formulation approaches to pediatric oral drug delivery: benefits and limitations of current platforms. Expert opinion on drug delivery. 2015;12(11):1727-1740.
• 2. Richey, R., Shah, U., Peak, M., Craig, J., Ford, J., Barker, C., Nunn, A., Turner, M. Manipulation of drugs to achieve the required dose is intrinsic to pediatric practice but is not supported by guidelines or evidence. BMC Pediatr. 2013;13(81):1-8.
• 3. Batchelor H, Marriott J: Formulations for children: problems and solutions. Br J Clin Pharmacol 2013;79(3):1-31.
• 4. Ivanovska, V., Rademaker, C. Dijk, L. Mantel-Teeuwisse A. Pediatric drug formulations: a review of challenges and progress. Pediatrics. 2014;134(2):361-372.
• 5. Kozarewicz, P. Regulatory perspectives on acceptability testing of dosage forms in children. Int J Pharm. 2014;469(2):245-248.
• 6. Wening, K., Breitkreutz, J., Oral drug delivery in personalized medicine: unmet needs and novel approaches. Int J Pharm. 2011;404(1-2):1-9.
• 7. Ithape, P., Ghadage, P., Gadhve, J., Mali, A. Oral Drug Delivery System Challenges to Pediatrics and Current Approaches. PharmaTutor. 2018;6(6):9-13.
• 8. Kytariolos, J., Charkoftaki, G., Smith, J. Stability and physicochemical characterization of novel milk-based oral formulations. Int J Pharm. 2013;444(1-2):128-138.
• 9. Charkoftaki, G., Kytariolos, J., Macheras, P. Novel milk-based oral formulations: proof of concept. Int J Pharm. 2010;390(2):150-159.
• 10. Monteagudo, E., Langenheim, M., Salerno, C. Pharmaceutical optimization of lipid-based dosage forms for the improvement of taste-masking, chemical stability and solubilizing capacity of phenobarbital. Drug Develop Indust Pharm. 2014;40(6):783-792.
• 11. Cun˜a, M., Vila, J. J., Torres, D. Controlled-release liquid suspensions based on ion-exchange particles entrapped within acrylic microcapsules. Int J Pharm. 2000;199(2):151-158.
• 12. Childress, A., Sallee, F. The use of methylphenidate hydrochloride extendedrelease oral suspension for the treatment of ADHD. Expert Rev Neurother. 2013;13(9):979-988.
• 13. Amrol, D. Single-dose azithromycin microsphere formulation: a novel delivery system for antibiotics. Int J Nanomed. 2007;2(1):9-12.
• 14. Walsh, J., Bickmann, D., Breitkreutz, J. Delivery devices for the administration of paediatric formulations: overview of current practice, challenges and recent developments. Int J Pharm. 2011;415(1-2):221-231.
• 15. Richter, F. Sipping devices: new technologies. 2021 Jan 10. Available from: http://www.raumedic.com/fileadmin/user_upload/PDF/drug-delivery-sipping-device.pdf [Website]
• 16. Just Milk. Safely delivering drugs and nutrients to breastfeeding infants. 2021 Feb 21 Available from: http://www.justmilk.org [website]
• 17. Gerrard, S., Baniecki, M., Sokal, D. A nipple shield delivery system for oral drug delivery to breastfeeding infants: microbicide delivery to inactivate HIV. Int J Pharm. 2012;434(1-2):224-234.
• 18. Thomson, S., Tuleu, C., Wong, I. Minitablets: new modality to deliver medicines to preschool-aged children. Pediatrics 2009;123(2):235-238.
• 19. Spomer, N., Klingmann, V. Stoltenberg I: Acceptance of uncoated minitablets in young children: results from a prospective exploratory cross-over study. Arch Dis Childhood. 2012;97(3):283-286.
• 20. Kayitare, E., Vervaet, C., Ntawukulilyayo, J. Development of fixed dose combination tablets containing zidovudine and lamivudine for paediatric applications. Int J Pharm. 2009;370(1-2):41-46.
• 21. Solomon, L., Kaplan, A. Method of administering a partial dose using segmented pharmaceutical tablet. US0031494, 2007.
• 22. Margiocco, M., Warren, J., Borgarelli, M. Analysis of weight uniformity, content uniformity and 30-day stability in halves and quarters of routinely prescribed cardiovascular medications. J Veter Cardiol. 2009;11(1):31-39.
• 23. van Riet-Nales, D., Doeve, M., Nicia, A. The accuracy, precision and sustainability of different techniques for tablet subdivision: breaking by hand and the use of tablet splitters or a kitchen knife. Int J Pharm. 2014;466(1-2):44-51.
• 24. Meltzer, E., Welch, M., Ostrom, N. Pill swallowing ability and training in children 6 to 11 years of age. Clin Pediatr. 2006;45(8):725-733.
• 25. Wening, K., Breitkreutz, J. Novel delivery device for monolithical solid oral dosage forms for personalized medicine. Int J Pharm. 2010;395(1-2):174-181.
• 26. Thomson, S., Tuleu, C., Wong, I. Minitablets: new modality to deliver medicines to preschool-aged children. Pediatrics. 2009;123(2):235-238.
• 27. Zedler, B., Kakad, P., Colilla, S. Does packaging with a calendar feature improve adherence to self-administered medication for long-term use? A systematic review. Clin Therap. 2011;33(1):62-73.
• 28. Food and Drugs Administration. Guidance for Industry: Size of beads in drug products labeled for sprinkle 2012; 2021 Feb 25. Available from: http://www.fda.gov/ downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM240243.pdf [Website]
• 29. Kluk, A., Sznitowska, M. Application properties of oral gels as media for administration of minitablets and pellets to paediatric patients. Int J Pharm. 2014;460(1-2):228-233.
• 30. World Health Organisation. WHO model formulary for children 2010. 2021 30 April. Available from: www.who.int/selection_ medicines/list/WMFc_2010.pdf [Website]
• 31. Batchelor, H., Fotaki, N., Klein, S. Paediatric oral biopharmaceutics: key considerations and current challenges. Adv Drug Delivery Rev. 2014;73:102-126.
• 32. Albertini, B., Di Sabatino, M., Melegari, C. Formulating SLMs as oral pulsatile system for potential delivery of melatonin to pediatric population. Int. J. Pharm. 2014;469(1):67-79.
• 33. Desai, D., Wang, J., Wen, H. Formulation design, challenges, and development considerations for fixed dose combination (FDC) of oral solid dosage forms. Pharma Develop Technol. 2013;18(6):1265-1276.
• 34. Bouffard, J., Dumont, H., Bertrand, F. Optimization and scale-up of a fluid bed tangential spray rotogranulation process. Int J Pharm. 2007;335(1-2):54-62.
• 35. Capsugel. Coni-Snap sprinkle capsules; 2021 March 3. Available from: Easy-Open Capsugel® Coni-Snap® Sprinkle Capsule | Lonza CHI [Website]
• 36. Hofmanova; J., Bennett, B., Coupe, A., Bartlett, J., Monahan, A., Katharine, H. A Novel Oral Syringe for Dosing and Administration of Multiparticulate Formulations: Acceptability Study in Preschool and School Children. Pharmaceutics. 2020;12(9):806.
• 37. Walsh, J., Bickmann, D., Breitkreutz, J. Delivery devices for the administration of paediatric formulations: overview of current practice, challenges and recent developments. Int J Pharm. 2011;415(1-2):221-231.
• 38. Gupta, M., Kumar, Y. Characterization of Orodispersible Films: An Overview of Methods and Introduction to a New Disintegration Test Apparatus Using LDR - LED Sensors. Journal of Pharmaceutical Science. 2020;109(10):2925-2942.
• 39. Lam, J. K., Xu, Y., Worsley, A., Wong, I. Oral transmucosal drug delivery for pediatric use. Adv Drug Deliv Rev. 201;73:50-62.
• 40. Slavkova, M., Breitkreutz, J. Orodispersible drug formulations for children and elderly. Eur J Pharm Sci. 2015;75:2-9.
• 41. De Caro, V., Giandalia, G., Siragusa, M., Sutera, F., Giannola, L. New prospective in treatment of Parkinson's disease: studies on permeation of ropinirole through buccal mucosa. Int J Pharm. 2012;429(1-2):78-83.
• 42. Hoffmann, E., Breitenbach, A. Advances in orodispersible films for drug delivery. Expert Opin Drug Delivery. 2011;8(3):299-316.
• 43. Mura, P., Mennini, N., Kosalec, I. Amidated pectin-based wafers for econazole buccal delivery: Formulation optimization and antimicrobial efficacy estimation. Carbohydr Polym. 2015;121:231-240.
• 44. Yu, D., Shen, X., Branford-White, C. Oral fast-dissolving drug delivery membranes prepared from electrospun polyvinylpyrrolidone ultrafine fibers. Nanotechnology, 2009; 20(5):1-9.
• 45. Buanz, A., Saunders, M., Basit, A. Preparation of personalized-dose salbutamol sulphate oral films with thermal ink-jet printing. Pharm Res. 2011;28(10):2386-2392.
• 46. Market Wired. Paladin submits patent application for thinsol, a novel oral ingestible film composition delivery system 2007. 2021 March 15. Available from: http:// www.marketwired.com/press-release/ paladin-submits-patent-applicationthinsol-novel-oral-ingestible-filmcomposition-tsx-plb-789353.ht [Website]
• 47. Aprecia Pharmaceuticals. ZipDose Technology 2014. 2021 March 15. Available from: https://www.aprecia.com/zipdoseplatform/zipdose-technology.php [Website]
• 48. Steiner, D., Finke, J., Kwade, A. SOFTs - Structured orodispersible film templates. Eur J Pharm Biopharm. 2019;137:209-217.
• 49. Buck., M., Health, C. Alternative forms of oral drug delivery for pediatric patients. Pediatr Pharmacother. 2013;19:3.
• 50. Nagaraju, T., Gowthami, R., Rajashekar, M. Comprehensive review on oral disintegrating films. Curr Drug Delivery. 2013;10(1):96-108.
• 51. Food and Drugs Administration. ZUPLENZ Oral Soluble Film prescribing information 2013. 2021 March 19 Available from: http://www.accessdata.fda.gov/ drugsatfda_docs/ label/2013/022524s002lbl.pdf [Website]
• 52. Rodd, C., Jean-Philippe, S., Vanstone, C., Weiler, H. Comparison of 2 vitamin D supplementation modalities in newborns: adherence and preference. Appl Physiol Nutr Metab. 2011;36(3):414-418.
• 53. Ranmal, S. R., O'Brien, F., Lopez, F. Methodologies for assessing the acceptability of oral formulations among children and older adults: a systematic review. Drug Discov Today. 2018;23(4):830-847.
• 54. Gerrard, S., Walsh, J., Bowers, N., Salunke, S., Hershenson, S. Innovations in Pediatric Drug Formulations and Administration Technologies for Low Resource Settings. Pharmaceutics. 2019;11(10):518.
• 55. Liang, A., Chen, L. Fast-dissolving intraoral drug delivery systems. Expert Opin Ther Patents. 2001;11(6):981-986.
• 56. Gupta, D., Maurya, A., Varshney, M. Orodispersible tablets: An Overview of Formulation and Technology. World Journal of Pharmacy and Pharmaceutical Sciences. 2020;9(10):1406-1418.
• 57. Stoltenberg, I., Breitkreutz, J. Orally disintegrating mini-tablets (ODMTs)--a novel solid oral dosage form for paediatric use. Eur J Pharma Biopharma. 2011;78(3):462-469.
• 58. Walsh, J., Cram, A., Woertz, K. Playing hide and seek with poorly tasting paediatric medicines: do not forget the excipients. Adv Drug Delivery Rev. 2014;73:14-33.
• 59. Stange, U., Fuhrling, C., Gieseler, H. Taste masking of naproxen sodium granules by fluid-bed coating. Pharma Develop Technol. 2014;19(2):137-147.
• 60. Venkatesh, G., Stevens, P., Lai, J. Development of orally disintegrating tablets comprising controlled-release multiparticulate beads. Drug Develop Indust Pharma. 2012;38(12):1428-40.
• 61. Shukla, D. Mouth Dissolving Tablets I. An overview of formulation technology. Scie Pharma. 2009;77(2):309-326.
• 62. Pharmaceutical & Medical Packaging news. New routes in oral dosing 2011. 2021 March 21; Available from: http://www.pmpnews. com/passport/oraldosing.html [Website]
• 63. Food and Drugs Administration. PREVACID medication guide. 2021 March 25; Available from: http://www.fda.gov/downloads/ Drugs/DrugSafety/UCM322354.pdf [Website]
• 64. Mishra, B., Sharma, G., Shukla, D. Investigation of organoleptic characteristics in the development of soft chews of calcium carbonate as mineral supplement. Yakugaku Zasshi 2009;129(12):1537-1544.
• 65. Michele, T., Knorr, B., Vadas, E. Safety of chewable tablets for children. J Asthma. 2002;39(5):391-403.
• 66. European Medicines Agency. Reflection paper Formulations of choice for the paediatric population. (EMEA/CHMP/PEG/194810/2005). 2021 March 31; Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003782.pd [Website]
• 67. Paulsen, N., Johnson, R., Coffee, M. Process for manufacturing chewable dosage forms for drug delivery and products thereof. US 8114455; 2012.
• 68. Hassan, E., Kindt, W., Roger, E. Chewable soft capsule. US08765174; 2014
• 69. Ko, C., Ko, J. J., Ko, Y., et al. Chewable softgel capsule, useful for encasing orally ingestible articles such as medicines and nutraceuticals, comprises an outer shell composition comprising gelatin, plasticizer, starch and an anti-tacking and softening agent. US092548; 2010
• 70. Hyrup, B., Andersen, C., Andreasen, L. The MediChew technology platform. Expert Opin Drug Delivery. 2005;2(5):927-933.
• 71. Ithape, P., Ghadage, P., Gadhve, J., Mali, A. Oral Drug Delivery System Challenges to Pediatrics and Current Apprpoaches. PharmaTutor 2018;6(6):9-13.