References
- Tomasi PA, Egger GF, Pallidis C, et al. Enabling development of paediatric medicines in Europe: 10 years of the eu paediatric regulation. Pediatr Drugs. 2017;19(6):505–513.
- EMA. ICH E11(R1) guideline on clinical investigation of medicinal products in the pediatric population. The Netherlands: EMA; 2017.
- EMA. Report from the commission to the European Parliament and the council: 10 years of the EU paediatric regulation. 2017.
- Walsh J, Schaufelberger D, Iurian S, et al. Path towards efficient paediatric formulation development based on partnering with clinical pharmacologists and clinicians, a conect4children expert group white paper. Br J Clin Pharmacol. 2021 April;1–18.
- Gore R, Chugh PK, Tripathi CD, et al. Pediatric off-label and unlicensed drug use and its implications. Curr Clin Pharmacol. 2017;12(1):18–25.
- Balan S, Hassali MAA, Mak VSL. Two decades of off-label prescribing in children: a literature review. World J Pediatr. 2018;14(6):528–540.
- EMA. Human medicines development and evaluation examples of key binding elements in the PIP decisions. 2013.
- Volkov S. (WHO) module 5: acceptability. Available from: https://docslib.org/doc/7409783/module-5-acceptability. [cited 2018 Dec 23].
- Penkov D, Tomasi P, Eichler I, et al. Pediatric medicine development: an overview and comparison of regulatory processes in the European Union and United States. Ther Innov Regul Sci. 2017;51(3):360–371.
- Toddler IF Developmental stages in infant and toddler feeding 2014. Available from: www.infantandtoddlerforum.org. [Cited 23 December 2021]
- O’Brien F, Clapham D, Krysiak K, et al. Making medicines baby size: the challenges in bridging the formulation gap in neonatal medicine. Int J Mol Sci. 20(11): 2688. 2019. 10.3390/ijms20112688.
- Wollmer E, Ungell AL, Nicolas JM, et al. Review of paediatric gastrointestinal physiology relevant to the absorption of orally administered medicines. Adv Drug Deliv Rev. 2022;181:114084. DOI:10.1016/j.addr.2021.114084.
- Neal-Kluever A, Fisher J, Grylack L, et al. Physiology of the neonatal gastrointestinal system relevant to the disposition of orally administered medications. Drug Metab Dispos. 2019;47(3):296–313.
- Lu H, Rosenbaum S. Developmental pharmacokinetics in pediatric populations. The Journal of Pediatric Pharmacology and Therapeutics. 2014;19(4):262–276.10.5863/1551-6776-19.4.262
- van den Anker J, Reed MD, Allegaert K, et al. Developmental changes in pharmacokinetics and pharmacodynamics. J Clin Pharmacol. 2018;58:S10–S25.
- Step. Committee for Medicinal Products for Human Use ICH guideline S11 on nonclinical safety testing in support of development of paediatric pharmaceuticals. 2020.
- Vinarov Z, Abdallah M, Agundez JAG, et al. Impact of gastrointestinal tract variability on oral drug absorption and pharmacokinetics: an UNGAP review. Eur J Pharm Sci. 2021;162:105812.
- EMA. Committee for medicinal products for human use (CHMP) and paediatric committee (PDCO) guideline on the investigation of medicinal products in the term and preterm neonate draft agreed by paediatric working party. The Netherlands: EMA; 2008.
- PMRU. Parent co-designed drug information for parents and guardians taking neonates home information sheet for parents/carers-E-survey. Available from:https://alderhey.nhs.uk/application/files/5716/3049/6335/Paddington_Parent_PIS_E-Survey_v2.0_27.05.2021.pdf. [cited 2021 Dec 23].
- NICE. Approximate Conversions and Units | about | BNF content published by NICE. Available from: https://bnf.nice.org.uk/about/approximate-conversions-and-units.html. [ Date Cited 23 December 2021]
- Garcia-Palop B, Movilla Polanco E, Cañete Ramirez C, et al. Harmful excipients in medicines for neonates in Spain. Int J Clin Pharm. 2016;38(2):238–242.
- Kogermann K, Lass J, Nellis G, et al. Age-Appropriate Formulations Including Pharmaceutical Excipients in Neonatal Medicines. Curr Pharm Des. 2017;23(38):5779–5789.
- Valeur KS, Holst H, Allegaert K. Excipients in neonatal medicinal products: never prescribed, commonly administered. Pharm Med. 2018;32(4):251–258.
- EMA. Quality of medicines questions and answers: part 2 | european Medicines Agency. The Netherlands: EMA; 2018.
- ClinicalTrials.gov. Clinical trials register. Available from: https://www.clinicaltrialsregister.eu/ctr-search/trial/. [Date Cited 23 December 2021]
- Ivanovska V, Rademaker CMA, Van Dijk L, et al. Pediatric drug formulations: a review of challenges and progress. Pediatrics. 2014;134(2):361–372.
- EMA. Committee for medicinal products for human use (CHMP) reflection paper: formulations of choice for the paediatric population. 2006. Report No.: 194810/2005.
- Walsh J, Ranmal SR, Ernest TB, et al. Patient acceptability, safety and access: a balancing act for selecting age-appropriate oral dosage forms for paediatric and geriatric populations. Int J Pharm. 2018;536(2):547–562.
- Kristensen HG. WHO guideline development of paediatric medicines: Points to consider in pharmaceutical development. International Journal of Pharmaceutics. 2012;435(2): 134–5.
- Mfoafo KA, Omidian M, Bertol CD, et al. Neonatal and pediatric oral drug delivery: hopes and hurdles. Int J Pharm. 2021;597:120296. October 2020. DOI:10.1016/j.ijpharm.2021.120296
- EMA. Committee for Medicinal Products for Human Use (CHMP) Paediatric Committee (PDCO) guideline on pharmaceutical development of medicines for paediatric use. The Netherlands: EMA; 2013.
- Spomer N, Klingmann V, Stoltenberg I, et al. Acceptance of uncoated mini-tablets in young children: results from a prospective exploratory cross-over study. Arch Dis Child. 2012;97(3):283–286.
- Klingmann V, Spomer N, Lerch C, et al. Favorable acceptance of mini-tablets compared with syrup: a randomized controlled trial in infants and preschool children. J Pediatr. 2013;163(6):1728–1732.
- Klingmann V. Acceptability of mini-tablets in young children: results from three prospective cross-over studies. AAPS PharmSciTech. 2017;18(2):263–266.
- Riet-Nales DA V, De Neef BJ, AFAM S, et al. Acceptability of different oral formulations in infants and preschool children. Arch Dis Child. 2013;98(9):725–731.
- Klingmann V, Seitz A, Meissner T, et al. Acceptability of uncoated mini-tablets in neonates—a randomized controlled trial. J Paediatr. 2015;167(4):893–6.e2.
- Riet-Nales DA V, Ferreira JA, AFAM S, et al. Methods of administering oral formulations and child acceptability. Int J Pharm. 2015;491(1–2):261–267.
- Klingmann V, Linderskamp H, Meissner TM, et al. Acceptability of multiple uncoated minitablets in infants and toddlers: a randomized controlled trial. J Pediatr. 2018;201:202–207.
- Orlu M, Ranmal SR, Sheng Y, et al. Acceptability of orodispersible films for delivery of medicines to infants and preschool children. Drug Deliv. 2017;24(1):1243–1248.
- Klingmann V, Pohly CE, Meissner T, et al. Acceptability of an orodispersible film compared to syrup in neonates and infants: a randomized controlled trial. Eur J Pharm Biopharm. 2020 February;151:239–245.
- Strickley RG. Pediatric oral formulations: an updated review of commercially available pediatric oral formulations since 2007. J Pharm Sci. 2019;108(4):1335–1365.
- Freerks L, Sommerfeldt J, Löper PC, et al. Safe, swallowable and palatable paediatric mini-tablet formulations for a WHO model list of essential medicines for children compound – a promising starting point for future PUMA applications. Eur J Pharm Biopharm. 2020;156:11–19.
- Zhang D, Rumondor ACF, Zhu W, et al. The development of minitablets for a pediatric dosage form for a combination therapy. J Pharm Sci. 2020;109(12):3590–3597. DOI:10.1016/j.xphs.2020.08.021.
- Thomson SA, Tuleu C, Wong ICK, et al. Minitablets: new modality to deliver medicines to preschool-aged children. Pediatrics. 2009;123(2):e235–e238.
- Stoltenberg I, Breitkreutz J. Orally disintegrating mini-tablets (ODMTs) - A novel solid oral dosage form for paediatric use. Eur J Pharm Biopharm. 2011;78(3):462–469.
- EMC. Slenyto 1 mg prolonged-release tablets - Summary of Product Characteristics (SmPC) - (emc). Available from: https://www.medicines.org.uk/emc/product/10023/smpc#. [ Date Cited 23 December 2021]
- EMC. Pancrease HL Capsules - Summary of Product Characteristics (SmPC) - (emc). Available from: https://www.medicines.org.uk/emc/product/1511/smpc#gref. [Date Cited 23 December 2021]
- Musiime V, Fillekes Q, Kekitiinwa A, et al. The pharmacokinetics and acceptability of lopinavir/ritonavir minitab sprinkles, tablets, and syrups in african HIV-infected children. J Acquired Immune Deficiency Syndromes. 2014;66(2):148–154. DOI:10.1097/QAI.0000000000000135.
- Unitaid. Innovative delivery systems for technology landscape. 2020. Report No.: 9789240008182.
- Mistry P, Batchelor H. Evidence of acceptability of oral paediatric medicines: a review. J Pharm Pharmacol. 2017;69(4):361–376.
- Malati CY, Golin R, O’Brien L, et al. Pursuing use of optimal formulations for paediatric HIV epidemic control – a look at the use of LPV/r oral pellets and oral granules. J Int AIDS Soc. 2019;22(4).
- UNICEF. Supply Catalogue LPV/r 40+10mg pellets in caps/PAC-120. Available from: https://supply.unicef.org/s0003668.html. [Date Cited 23 December 2021]
- Weitz DM Lopinavir and ritonavir oral pellets, 40 mg/1 0 mg. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205425Orig1s000TAltr.pdf. [ Date Cited 23 December 2021]
- Ltd BC ISRCTN registry Children with HIV in Africa - Pharmacokinetics and Adherence of Simple Antiretroviral Regimens (CHAPAS-2). Available from: http://www.isrctn.com/ISRCTN01946535. [ Cited 23 December 2021]
- WHO. Application for inclusion of Lopinavir /Ritonavir Oral Granules (LPV/r) Formulation on WHO model list of essential medicines for children. Available from: https://www.who.int/selection_medicines/committees/expert/22/applications/s6.4.2.3_lopinavir-ritonavir.pdf?ua=1. [Cited 23 December 2021]
- Insight SA Lopinavir/ritonavir sprinkle formulation - cipla - adisinsight. Available from: https://adisinsight.springer.com/drugs/800040408. [Cited 23 December 2021]
- ClinicalTrials.gov. Lopinavir/r/ Lamivudine/ Abacavir as an easy to use paediatric formulation - full text view - clinicalTrials.gov. Available from: https://clinicaltrials.gov/ct2/show/NCT03836833. [Cited 23 December 2021]
- Initiative DfND. Study for a child-friendly HIV treatment begins in Uganda. Available from: https://dndi.org/news/2019/study-for-a-child-friendly-hiv-treatment-begins-in-uganda/. [Cited 23 December 2021]
- Plan PHIVA. Mylan | paediatric HIV. Available from: https://www.paediatrichivactionplan.org/mylan. [ Cited 23 December 2021]
- FDA. Highlights of prescribing information - Reyataz. Available from: www.fda.gov/medwatch. [Cited 23 December 2021]
- CHMP. Pyramax, INN - pyronaridine tetraphosphate /artesunate. Available from: https://www.ema.europa.eu/en/documents/medicine-outside-eu/pyramax-product-information_en.pdf. [ Cited 23 December 2021]
- Sagara I, Beavogui AH, Zongo I, et al. Safety and efficacy of re-treatments with pyronaridine-artesunate in African patients with malaria: a substudy of the WANECAM randomised trial. Lancet Infect Dis. 2016;16(2):189–198. DOI:10.1016/S1473-3099(15)00318-7.
- Sagara I, Beavogui AH, Zongo I, et al. Pyronaridine–artesunate or dihydroartemisinin–piperaquine versus current first-line therapies for repeated treatment of uncomplicated malaria: a randomised, multicentre, open-label, longitudinal, controlled, phase 3b/4 trial. Lancet. 2018;391(10128):1378–1390. DOI:10.1016/S0140-6736(18)30291-5.
- EMC. Desitrend 250 mg coated granules in sachet - Summary of Product Characteristics (SmPC) 2019. Available from: https://www.medicines.org.uk/emc/product/2883/smpc#. [Cited 23 December 2021]
- EMC. Desitrend Patient Leaflet 2019. Available from: https://www.medicines.org.uk/emc/files/pil.2883.pdf. [Cited 23 December 2021]
- Pharma D Desitrend ® (levetiracetam minitablets) formulary document 2016. 1-6]. Available from: https://desitin.co.uk/wp-content/uploads/2014/06/Desitrend-Formulary-Document-Nov-2016-DD_0003-CERT.pdf. [ Cited 23 December 2021]
- EMC. Episenta 500 mg prolonged-release granules - Summary of Product Characteristics (SmPC) - (emc). Available from: https://www.medicines.org.uk/emc/product/325/smpc#PRECLINICAL_SAFETY. [Cited 23 December 2021]
- BNFc. Sodium valproate | drug | bNFc content published by NICE. Available from: https://bnfc.nice.org.uk/drug/sodium-valproate.html. [ Cited 23 December 2021]
- Verrotti A, Nanni G, Agostinelli S, et al. Effects of the abrupt switch from solution to modified-release granule formulation of valproate. Acta Neurol Scand. 2012;125(3):e14–e8. DOI:10.1111/j.1600-0404.2011.01568.x.
- EMC. Epilim chronosphere MR 100 mg modified release granules - Summary of Product Characteristics (SmPC) - (emc). Available from: https://www.medicines.org.uk/emc/product/6301/smpc#gref. [Cited 23 December 2021]
- EMC. Hidrasec 10 mg, granules for oral suspension - Summary of Product Characteristics (SmPC) - (emc). Available from: https://www.medicines.org.uk/emc/product/5065. [ Cited 23 December 2021]
- EMC. Creon micro pancreatin 60.12 mg gastro-resistant granules - Summary of Product Characteristics (SmPC) - (emc). Available from: https://www.medicines.org.uk/emc/product/5564/smpc#gref. [ Cited 23 December 2021]
- Creon. Creon micro pancreatin 60.12 mg gastro-resistant granules, creon 10000 capsules, creon 25000 capsules: prescribing information. Available from: https://www.creon.co.uk/-/media/creoncouk/assets/pdf/uk_pi_creon_021_final.pdf?la=en-gb. [ Cited 23 December 2021]
- ClinicalTrials.gov. Evaluation of safety and tolerability of creon micro in children younger than four years with pancreatic exocrine insufficiency - full text view - clinicalTrials.gov. Available from: https://clinicaltrials.gov/ct2/show/NCT01747330. [ Cited 23 December 2021]
- Kashirskaya NY, Kapranov NI, Sander-Struckmeier S, et al. Safety and efficacy of creon® micro in children with exocrine pancreatic insufficiency due to cystic fibrosis. J Cyst Fibros. 2015;14(2):275–281.
- Munck A, Duhamelb J-F, Lamireauc T, et al. Pancreatic enzyme replacement therapy for young cystic fibrosis patients. J Cyst Fibros. 2009;8(1):14–18. DOI:10.1016/j.jcf.2008.07.003.
- Vertex. How to take kalydeco® (ivacaftor) | oral Granules or Tablets. Available from: https://www.kalydeco.com/how-to-take-kalydeco. [Cited 23 December 2021]
- Vertex. What is kalydeco? Available from: https://www.kalydeco.com/sites/default/files/patient-brochure.pdf. [Cited 23 December 2021]
- EMC. Kalydeco 50 mg granules in sachet - Summary of Product Characteristics (SmPC) - (emc). Available from: https://www.medicines.org.uk/emc/product/1954/smpc#gref. [Cited 23 December 2021]
- EMC. Alkindi 0.5 mg granules in capsules for opening - Summary of Product Characteristics (SmPC) - (emc). Available from: https://www.medicines.org.uk/emc/product/9032/smpc. [ Cited 23 December 2021]
- EMC. Granupas 4 g gastro-resistant granules - Summary of Product Characteristics (SmPC) - (emc). Available from: https://www.medicines.org.uk/emc/product/11439/smpc#gref. [Cited 23 December 2021]
- EMC. Nexium 10 mg gastro-resistant granules for oral suspension, sachet - Summary of Product Characteristics (SmPC) - (emc). Available from: https://www.medicines.org.uk/emc/product/6674/smpc. [Cited 23 December 2021]
- FDA. Highlights of prescribing information for aciphex®. aciphex® (rabeprazole sodium) delayed-release tablets, for oral use. Available from: www.fda.gov/medwatch. [Cited 23 December 2021]
- FDA. Prevacid (lansoprazole). Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020406s078-021428s025lbl.pdf. [Cited 23 December 2021]
- FDA. Vistogard. Available from: www.fda.gov/medwatch Cited 23 December 2021.
- FDA. Xuriden. Available from: www.fda.gov/medwatch Cited 23 December 2021.
- 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(11):1727–1740.
- Gargano N, Madrid L, Valentini G, et al. Efficacy and tolerability outcomes of a phase II, randomized, open-label, multicenter study of a new water-dispersible pediatric formulation of dihydroartemisinin-piperaquine for the treatment of uncomplicated plasmodium falciparum malaria in African infa. Antimicrob Agents Chemother. 2018;62(1). DOI:10.1128/AAC.00596-17.
- ClinicalTrials.gov. A pharmacokinetic/pharmacodynamic study of eurartesim dispersible formulation in infants with p.falciparum malaria 2016. Available from: https://clinicaltrials.gov/ct2/show/NCT01992900. [Cited 23 December 2021]
- Liu F, Ranmal S, Batchelor HK, et al. Patient-centered pharmaceutical design to improve acceptability of medicines: similarities and differences in paediatric and geriatric populations. Drugs. 2014;74(16):1871–1889. DOI:10.1007/s40265-014-0297-2.
- Preis M. Mini-review orally disintegrating films and mini-tablets-innovative dosage forms of choice for pediatric use. AAPS PharmSciTech. 2015;16(2):234–241.
- Bajcetic M, de Wildt SN, Dalinghaus M, et al. Orodispersible minitablets of enalapril for use in children with heart failure (Lena): rationale and protocol for a multicentre pharmacokinetic bridging study and follow-up safety study. Contemp Clin Trials Commun. 2019;15.
- Kimura SI, Uchida S, Kanada K, et al. Effect of granule properties on rough mouth feel and palatability of orally disintegrating tablets. Int J Pharm. 2015;484(1–2):156–162.
- EMC. Kigabeq 100 mg soluble tablets - Summary of Product Characteristics (SmPC) - (emc). Available from: https://www.medicines.org.uk/emc/product/11069. [ Cited 23 December 2021]
- Venture Mf M SPAQ-CO™/Supyra® (sulfadoxine-pyrimethamine + amodiaquine) for seasonal preventive treatment of malaria | medicines for Malaria Venture. Available from: https://www.mmv.org/access/products-projects/spaq-co-supyra-sulfadoxine-pyrimethamine-amodiaquine-seasonal-preventive. [Cited 23 December 2021]
- Venture Mf M SPAQ-CO™ dispersible | medicines for Malaria Venture 2020. Available from: https://www.mmv.org/research-development/project-portfolio/spaq-co-dispersible. [Cited 23 December 2021]
- WHO. Addition of amodiaquine + sulfadoxine-pyrimethamine for seasonal malaria chemoprevention in the WHO model list of essential medicines for children general items. Available from: http://www.who.int/malaria/publications/atoz/9789241504737/en/. [Cited 23 December 2021]
- NAFDAC. National Agency for Food & Drug Administration & Control (NAFDAC) Registration & Regulatory Affairs (R & R) Directorate. Available from: https://www.nafdac.gov.ng/wp-content/uploads/Files/SMPC/SUPYRA150mg-500mg-25mg.pdf. [ Cited 23 December 2021]
- EMC. Amoxicillin 1000mg dispersible tablets - Summary of Product Characteristics (SmPC) - (emc). Available from: https://www.medicines.org.uk/emc/product/11433/smpc#POSOLOGY. [ Cited 23 December 2021]
- WHO. WHO model list of essential medicines application information to be included with an application for inclusion, change or deletion of a medicine in the who model list of essential medicines. Available from: https://www.who.int/selection_medicines/committees/expert/21/applications/s6_abacavir_lamivudine_form.pdf. [Cited 23 December 2021]
- Composition Q Abacavir (as sulfate)/Lamivudine 120 mg/60 mg dispersible tablets. Available from: https://www.fdaghana.gov.gh/img/smpc/AbacavirLamivudine120,60mgtablet.pdf [ Cited 23 December 2021]
- WHO. Application to 21st WHO expert committee on the selection and use of essential medicines to include the childhood tb fixed-dose combinations into the who model list of essential medicines for children. Available from: https://www.who.int/selection_medicines/committees/expert/21/applications/s6_isoniazid_pyrazinamide_rifampicin_form.pdf?ua=1. [Cited 23 December 2021]
- Tablets D, This O Rifampicin/Isoniazid/Pyrazinamide 75mg/50mg/150mg dispersible tablets (macleods pharmaceuticals limited), TB309 2010. 1–5]. Available from: https://extranet.who.int/pqweb/sites/default/files/TB309part6v1.pdf. [Cited 23 December 2021]
- FDA. Tracleer - highlights of prescribing information. Available from: www.fda.gov/medwatch. [Cited 23 December 2021]
- EMC. Ucedane 200 mg dispersible tablets - Summary of Product Characteristics (SmPC) - (emc). Available from: https://www.medicines.org.uk/emc/product/11441/smpc#gref. [Cited 23 December 2021]
- EMC. Carbaglu 200 mg dispersible tablets - Summary of Product Characteristics (SmPC) - (emc). Available from: https://www.medicines.org.uk/emc/product/6234/smpc#gref. [Cited 23 December 2021]
- EMC. Zofran Melt 4mg - Summary of Product Characteristics (SmPC) - (emc). Available from: https://www.medicines.org.uk/emc/product/194/smpc#gref. [Cited 23 December 2021]
- EMC. Setofilm 4mg Orodispersible Films - Summary of Product Characteristics (SmPC) - (emc). Available from: https://www.medicines.org.uk/emc/product/9595/smpc#gref. [Cited 23 December 2021]
- Ryukakusan Co L. Swallowing aid jelly (magic jelly). Available from: https://www.ryukakusan.co.jp/productjelly/en. [Cited 23 December 2021]
- Gloup. Gloup - for patients. Available from: https://gloup.shop/for-patients/children/. [ Cited 23 December 2021]
- AdarePharmaSolutions. Parvulet© - Patient Centric Dosage Solution- Adare Pharma Solutions. Available from: https://www.adarepharmasolutions.com/technologies/parvulet/. [Cited 23 December 2021]
- Salim M, Ramirez G, Peng K-Y, et al. Lipid compositions in infant formulas affect the solubilization ofantimalarial drugs artefenomel (OZ439) and Ferroquine duringDigestion. Mol Pharm. 2020;17(7):2749–2759. DOI:10.1021/acs.molpharmaceut.0c00475.
- Abu Bakar SY B, Salim M, Clulow AJ, et al. Revisiting dispersible milk-drug tablets as a solid lipid formulation in the context of digestion. Int J Pharm. 2019;554:179–189.
- Bennett SM, Zhou L, Hayes JE. Using milk fat to reduce the irritation and bitter taste of ibuprofen. Chemosensory Perception. 2012;5(3–4):231–236.10.1007/s12078-012-9128-6
- MedibottleTm. medibottle® - the pediatric medication delivery system - medibottle outperforms the industry standard oral syringe! Available from: http://www.medibottle.com/home.html. [Cited 23 December 2021]
- Maier T, Kerbs A, Fruk L, et al. Iron delivery from liquid-core hydrogels within a therapeutic nipple shield. Eur J Pharm Sci. 2019 January;131:119–126.
- EMA. Human medicines development and evaluation list of criteria for screening PIPs with regard to paediatric specific quality issues and referring them to the PDCO FWG for discussion. 2013.
- HS design. Sympfiny - HS Design. Available from: https://hs-design.com/sympfiny/. [ Cited 23 December 2021]
- Technology DS XStraw » DS Technology. Available from: https://d-s.technology/xstraw/. [ Cited 23 December 2021]
- Araújo MRP, Sa-Barreto LL, Gratieri T, et al. The digital pharmacies era: how 3D printing technology using fused deposition modeling can become a reality. Pharmaceutics. 2019;11(3):128.
- Tian Y, Orlu M, Woerdenbag HJ, et al. Oromucosal films: from patient centricity to production by printing techniques. Expert Opin Drug Deliv. 2019;16(9):981–993. DOI:10.1080/17425247.2019.1652595.
- Preis M, Öblom H. 3D-printed drugs for children—are we ready yet? AAPS PharmSciTech. 2017;18(2):303–308.
- Rautamo M, Kvarnström K, Sivén M, et al. Benefits and prerequisites associated with the adoption of oral 3D-printed medicines for pediatric patients: a focus group study among healthcare professionals. Pharmaceutics. 2020;12(3):229.
- Aprecia P Achieving high drug load with rapid dispersion using 3D printing. Available from: https://www.aprecia.com/whitepaper/redefining-fast-melt-for-pharma. [Date Cited 23 December 2021]
- Jain P. Rectal suppositories in children: ‘up’ may be the way to go! Indian Pediatr. 2019;56(6):497.
- Hanning SM, Matiz S, Krasser K, et al. Characterisation of rectal amoxicillin (RAMOX) for the treatment of pneumonia in children. Drug Deliv Transl Res. 2020;11(3):944–955.
- Chen L, Zhang M, Yung J, et al. Safety of rectal administration of acetaminophen in neonates. Cjhp. 2018;71(6):6.
- Demir N, Peker E, İ E, et al. Efficacy and safety of rectal ibuprofen for patent ductus arteriosus closure in very low birth weight preterm infants. J Matern Fetal Neonatal Med. 2017;30(17):2119–2125.
- Livingston MH, Zequeira J, Blinder H, et al. Glycerin suppositories used prophylactically in premature infants (SUPP) trial: a study protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2015;1(1). DOI:10.1186/s40814-015-0024-0
- Livingston MH, Elliott T, Williams C, et al. Glycerin suppositories used prophylactically in premature infants (supp): a pilot randomized controlled trial. J Neonatal Perinatal Med. 2020;13(4):495–505.
- Anderson BJ, Van Lingen RA, Hansen TG, et al. Acetaminophen developmental pharmacokinetics in premature neonates and infants. American Society of Anesthesiologists. 2002;96:1336–1345.
- Van Lingen RA, Deinum JT, Quak JME, et al. Pharmacokinetics and metabolism of rectally administered paracetamol in preterm neonates. Arch Dis Child Fetal Neonatal Ed. 1999;80(1):F59–F63. DOI:10.1136/fn.80.1.F59.
- Vanlingen R, Deinum H, Quak C, et al. Multiple-dose pharmacokinetics of rectally administered Acetaminophen in term infants. Clin Pharmacol Ther. 1999;66(5):509–515.
- Tozan Y, Klein EY, Darley S, et al. Prereferral rectal artesunate for treatment of severe childhood malaria: a cost-effectiveness analysis. Lancet. 2010;376(9756):1910–1915.
- Persaud S, Eid S, Swiderski N, et al. Preparations of rectal suppositories containing artesunate. Pharmaceutics. 2020;12(3):222.
- Kauss T, Langlois MH, Guyonnet-Dupérat A, et al. Development of rectodispersible tablets and granulate capsules for the treatment of serious neonatal sepsis in developing countries. J Pharm Sci. 2019;108(8):2805–2813. DOI:10.1016/j.xphs.2019.03.004.
- Katata-Seru L, Ojo BM, Okubanjo O, et al. Nanoformulated Eudragit lopinavir and preliminary release of its loaded suppositories. Heliyon. 2020;6(5):e03890.
- Christ AP, Biscaino PT, Lourenço RL, et al. Development of doxycycline hyclate suppositories and pharmacokinetic study in rabbits. Eur J Pharm Sci. 2020;142:105141. November 2019. DOI:10.1016/j.ejps.2019.105141
- Seth N, Llewellyn NE, Howard RF. Parental opinions regarding the route of administration of analgesic medication in children. Paediatr Anaesth. 2000;10(5):537–544.
- Hanning SM, Walker E, Sutcliffe E, et al. The rectal route of medicine administration for children: let’s get to the bottom of it! Eur J Pharm Biopharm. 2020;157:25–27.
- EMC. Flagyl 500mg Suppositories - Summary of Product Characteristics (SmPC) - (emc). Available from: https://www.medicines.org.uk/emc/product/9240/smpc#gref. [Cited 23 December 2021]
- EMC. Voltarol Suppositories - Summary of Product Characteristics (SmPC) - (emc). Available from: https://www.medicines.org.uk/emc/medicine/1344#gref. [Cited 23 December 2021]
- EMC. Zofran Suppositories - Summary of Product Characteristics (SmPC) - (emc). Available from: https://www.medicines.org.uk/emc/medicine/785/SPC/#gref. [Cited 23 December 2021]
- Venture Mf M Artesunate rectal capsules: a pre-referral intervention for children with severe malaria | medicines for Malaria Venture. Available from: https://www.mmv.org/access/products-projects/artesunate-rectal-capsules-pre-referral-intervention-children-severe. [Cited 23 December 2021]
- Venture Mf M Approved/ERP | medicines for Malaria Venture. Available from: https://www.mmv.org/portfolio-type/approvederp. [Cited 23 December 2021]
- EMC. Epilim Liquid 200 mg/5 ml - Summary of Product Characteristics (SmPC) - (emc). Available from: https://www.medicines.org.uk/emc/product/517/smpc#gref. [Cited 23 December 2021]
- EMC. Sodium Valproate 40mg/ml Oral Solution (sugar free) - Summary of Product Characteristics (SmPC) - (emc). Available from: https://www.medicines.org.uk/emc/product/6969/smpc#gref. [Cited 23 December 2021]
- Group NPP. Administration of rectal diazepam to neonates and infants to treat seizures prior to hospital admission 2022. Available from: http://nppg.org.uk/wp-content/uploads/2022/02/NPPG-Position-Statement-Diazepam-V1.pdf. [Cited 23 December 2021]
- EMC. Diazepam Desitin 5 mg Rectal solution - Summary of Product Characteristics (SmPC) - (emc) 2019. Available from: https://www.medicines.org.uk/emc/product/2997/smpc. [Cited 23 December 2021]
- EMC. Diazepam RecTubes 10mg Rectal Solution - Summary of Product Characteristics (SmPC) - (emc) 2020. Available from: https://www.medicines.org.uk/emc/product/6799/smpc. [Cited 23 December 2021]