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儿童口服给药固体新剂型研究进展

孙军娣, 张自强, 何淑旺, 姚静

孙军娣, 张自强, 何淑旺, 姚静. 儿童口服给药固体新剂型研究进展[J]. 中国药科大学学报, 2019, 50(6): 631-640. DOI: 10.11665/j.issn.1000-5048.20190601
引用本文: 孙军娣, 张自强, 何淑旺, 姚静. 儿童口服给药固体新剂型研究进展[J]. 中国药科大学学报, 2019, 50(6): 631-640. DOI: 10.11665/j.issn.1000-5048.20190601
SUN Jundi, ZHANG Ziqiang, HE Shuwang, YAO Jing. Progress on novel pediatric oral solid dosage forms[J]. Journal of China Pharmaceutical University, 2019, 50(6): 631-640. DOI: 10.11665/j.issn.1000-5048.20190601
Citation: SUN Jundi, ZHANG Ziqiang, HE Shuwang, YAO Jing. Progress on novel pediatric oral solid dosage forms[J]. Journal of China Pharmaceutical University, 2019, 50(6): 631-640. DOI: 10.11665/j.issn.1000-5048.20190601

儿童口服给药固体新剂型研究进展

基金项目: 国家重大新药创制科技重大专项资助项目(No.2018ZX09721003-007-005)

Progress on novel pediatric oral solid dosage forms

  • 摘要: 中国儿童药物不良反应发生率是成人的两倍,新生儿更是成年人的4倍,其主要原因是儿童生理指标处于不断变化的过程中,临床上缺乏适合于各个年龄阶段的儿童药物。儿童药,尤其是便于服用、方便贮存的儿童口服固体制剂的开发成为新药研究人员关注的焦点。本文从多微粒制剂、口崩片、咀嚼片等方面综述了适用于儿童的各种新型口服固体制剂,同时指出高效的掩味技术和准确的给药剂量有助于儿童口服给药固体剂型的开发,是今后该类药物进一步研究的方向,以期对今后儿童口服给药固体剂型的研究提供理论参考。
    Abstract: In China, the incidence of adverse reactions of drugs in children is twice that in adults; especially in the newborns, it is four times that in adults. The main reason is that the physiological characteristics of children are changing constantly due to that they are in a constant process of growth and development; while the pediatric medicines cannot meet the clinical needs of children in different age states. Accordingly, the development of pediatric medicines, especially oral solid preparations which are convenient for administration and storage, has attracted a lot of attention. This review introduced various pediatric oral solid dosage forms such as multiparticulates, orally disintegrating tablets(ODT)and chewable tablets. In addition, the efficient taste masking technology and accurate dose control were the further research directions for development of pediatric medicines, which would provide important theoretical references for studies on pediatric oral solid dosage forms in future.
  • [1] Porter J,Withe M,Ross RJ.Immediate-release granule formulation of hydrocortisone,Alkindi®,for treatment of paediatric adrenal insufficiency(Infacort development programme)[J].Expert Rev Endocrinol Metab,2018,13(3):119-124.
    [2] Childress A,Belchenko D,Lempa B.The use of modified-release methylphenidate in the treatment of attention-deficit/hyperactivity disorder[J].Expert Rev Neurother,2017,17(2):113-121.
    [3] Burnside Beth A,Guo XD,Fiske K,et al.Oral pulsed dose drug delivery system:AU,20000012145D[P].2000-05-08.
    [4] Sun Pharmaceutical Industries Limited.Capsule dosage form of metoprolo succinate:US,9504655(B2)[P].2016-11-29.
    [5] Lickrish D,Zhang F.Methods for treatment of attention deficit hyperactivity disorder:US,8916588(B2)[P].2014-12-23.
    [6] Neeraj S,Masayuki I,Takashi M.Multi-unit drug delivery device for pulsatile or sustained release:EP,2586429(A1)[P].2013-05-01.
    [7] Balducci AG,Colombo G,Corace G,et al.Layered lipid microcapsules for mesalazine delayed-release in children[J].Int J Pharm,2011,421(2):293-300.
    [8] Wairkar S,Gaud R,Raghavan A.Multi-particulate systems:cutting-edge technology for controlled drug delivery[J].Recent Pat Drug Deliv Formul,2016,10(3):184-191.
    [9] Han R,Yang YL,Li XS,et al.Predicting oral disintegrating tablet formulations by neural network techniques[J].Asian J Pharm Sci,2018,13(4):336-342.
    [10] Martínez Terán ME,Flament MP.Development of multiparticulate orodispersible tablets for pediatric use[J].Int J Pharm,2016,511(2):1143.
    [11] Hoang Thi TH,Lhafidi S,Carneiro SP,et al.Feasability of a new process to produce fast disintegrating pellets as novel multiparticulate dosage form for pediatric use[J].Int J Pharm,2015,496(2):842-849.
    [12] Shang R,Liu C,Quan P,et al.Effect of drug-ion exchange resin complex in betahistine hydrochloride orodispersible film on sustained release,taste masking and hygroscopicity reduction[J].Int J Pharm,2018,545(1/2):163-169.
    [13] Tengler M,McMahen R.Compositions comprising methylphenidate complexed with ion- exchange resin particles:US,9089496(B2)[P].2015-07-28.
    [14] Elwerfalli AM,Al-Kinani A,Alany RG,et al.Nano-engineering chitosan particles to sustain the release of promethazine from orodispersables[J].Carbohydr Polym,2015,131:447-461.
    [15] Chen YD,Liang ZY,Cen YY,et al.Development of oral dispersible tablets containing prednisolone nanoparticles for the management of pediatric asthma[J].Drug Des Devel Ther,2015,9:5815-5825.
    [16] Elwerfalli AM,Ghanchi Z,Rashid F,et al.New generation of orally disintegrating tablets for sustained drug release:a propitious outlook[J].Curr Drug Deliv,2015,12(6):652-667.
    [17] Visser JC,Woerdenbag HJ,Hanff LM,et al.Personalized medicine in pediatrics:the clinical potential of orodispersible films[J].AAPS PharmSciTech,2017,18(2):267-272.
    [18] Visser JC,Woerdenbag HJ,Crediet S,et al.Orodispersible films in individualized pharmacotherapy:the development of a formulation for pharmacy preparations[J].Int J Pharm,2015,478(1):155-163.
    [19] Zhu Y,You XR,Huang KQ,et al.Effect of taste masking technology on fast dissolving oral film:dissolution rate and bioavailability[J].Nanotechnology,2018,29(30):1-21.
    [20] Ehtezazi T,Algellay M,Islam Y,et al.The application of 3D printing in the formulation of multilayered fast dissolving oral films[J].J Pharm Sci,2018,107(4):1076-1085.
    [21] Soroushnai A,Ganji F,Vasheghani-Farahani E,et al.Development and evaluation of an anti- epileptic oral fast-dissolving film with enhanced dissolution and in vivo permeation[J].Curr Drug Deliv,2018,15(9):1294-1304.
    [22] Pimparade MB,Vo A,Maurya AS,et al.Development and evaluation of an oral fast disintegrating anti-allergic film using hot-melt extrusion technology[J].Eur J Pharm Biopharm,2017,119:81-90.
    [23] Rustemkyzy C,Belton P,Qi S.Preparation and characterization of ultrarapidly dissolving orodispersible films for treating and preventing iodine deficiency in the pediatric population[J].J Agric Food Chem,2015,63(44):9831-9838.
    [24] Hayakawa Y,Uchida S,Namiki N.Evaluation of the ease of taking mini-tablets compared with other tablet formulations in healthy volunteers[J].Eur J Pharm Sci,2016,84:157-161.
    [25] El-Say KM,Ahmed TA,Abdelbary MF,et al.Risperidone oral disintegrating Mini-tablets:a robust-product for pediatrics[J].Acta Pharm,2015,65(4):365-382.
    [26] Aleksovski A,Dreu R,Gašperlin M,et al.Mini-tablets:a contemporary system for oral drug delivery in targeted patient groups[J].Expert Opin Drug Deliv,2015,12(1):65-84.
    [27] Monsuur F,Choudhari Y,Reddy U,et al.Solvent free amorphisation for pediatric formulations(minitablets)using mesoporous silica[J].Int J Pharm,2016,511(2):1135-1136.
    [28] Parissaux X,Druon A,Agnès W,et al.Synergy of maltitol and intense sweetener in taste masking of acetaminophen chewable tablets[J].Int J Pharm,2018,536(2):517-518.
    [29] Dille MJ,Hattrem MN,Draget KI.Soft,chewable gelatin-based pharmaceutical oral formulations:a technical approach[J].Pharm Dev Technol,2018,23(5):504-511.
    [30] Nour SA,Abdelmalak NS,Naguib MJ.Novel chewable colon targeted tablets of bumadizone calcium for treatment of ulcerative colitis:formulation and optimization[J].J Drug Deliv Sci Technol,2016,35:172-183.
    [31] Childress A,Ponce De Leon B,Owens M.QuilliChew extended-release chewable tablets for the treatment of ADHD in patients ages 6 years old and above[J].Expert Opin Drug Deliv,2018,15(12):1263-1270.
    [32] Al Hagbani T,Nazzal S.Medicated chewing gums(MCGs):composition,production,and mechanical testing[J].AAPS PharmSciTech,2018,19(7):2908-2920.
    [33] Al Hagbani T,Altomare C,Kamal MM,et al.Mechanical characterization and dissolution of chewing gum tablets(CGTs)containing co-compressed health in gum® and curcumin/cyclodextrin inclusion complex[J].AAPS PharmSciTech,2018,19(8):3742-3750.
    [34] Mohammadi N,Ehsani MR,Bakhoda H.Design and evaluation of the release characteristics of caffeine-loaded microcapsules in a medicated chewing gum formulation[J].Food Biophys,2018,13(3):240-249.
    [35] Buck J,Huwyler J,Kühl P,et al.Pediatric dispersible tablets:a modular approach for rapid prototyping[J].Pharm Res,2016,33(8):2043-2055.
    [36] Lal M,Lai M,Estrada M,et al.Developing a flexible pediatric dosage form for antiretroviral therapy:a fast-dissolving tablet[J].J Pharm Sci,2017,106(8):2173-2177.
    [37] Tian P,Yang F,Xu Y,et al.Oral disintegrating patient-tailored tablets of warfarin sodium produced by 3D printing[J].Drug Dev Ind Pharm,2018,44(12):1918-1923.
    [38] Chandrasekaran P, Kandasamy R. Development of extended-release oral flexible tablet(ER-OFT)formulation for pediatric and geriatric compliance:an age-appropriate formulation[J].AAPS PharmSciTech,2017,18(7):2394-2409.
    [39] Cantor SL,Khan MA,Gupta A.Development and optimization of taste-masked orally disintegrating tablets(ODTs)of clindamycin hydrochloride[J].Drug Dev Ind Pharm,2015,41(7):1156-1164.
    [40] Chandrasekaran P,Kandasamy R.Development of oral flexible tablet(OFT)formulation for pediatric and geriatric patients:a novel age-appropriate formulation platform[J].AAPS PharmSciTech,2017,18(6):1972-1986.
    [41] Lin W,Yan JH,Heimbach T,et al.Pediatric physiologically based pharmacokinetic model development:current status and challenges[J].Curr Pharmacol Rep,2018,4(6):491-501.
    [42] Wang DD,Lu JM,Li YZ,et al.Population pharmacokinetics of sirolimus in pediatric tuberous sclerosis complex:from real world study[J].Int J Clin Exp Med.2018,11(11):12302-12309.
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出版历程
  • 刊出日期:  2019-12-24

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