Innovative Child-Resistant Packaging for Pharmaceutical Solid Dosage Forms

  • Lalji BaldaniyaEmail author
  • Vaibhav Shah
  • Malav Maniar
  • Mukesh Gohel
  • Vaishali Thakkar
  • Tejal Gandhi
Research Article


The major oral solid medicines are sold in blister and strips packaging, which are packaged in a carton box. Children, who manage to open such boxes, while unsupervised, are in great danger of being poisoned by swallowing the contents. A CRP usually requires a special trick to open it. The aim was to design and validate the performance of innovative CRP system with unique features. Materials used were the plastic grade, click lock system, and blister pack. The test conducted on test panels of 100 healthy children between 42 and 51 months were asked to open a pack. Each panel divided into 3 groups, viz. 30 children of 42–44 months, 40 children 45–48 months, and 30 children 49–51 months. The panel of 100 healthy adults divided into 3 groups, viz. 25 adults 18–40 years, 25 adults 40–59 years, and 50 adults 60–70 years. Results shown only 6% of children succeeded to open CRP, while 94% failed to open CRP within 5 min. In the case of adults, 96% succeeded to open CRP without imposing any difficulties. There was a successful development of a prototype of CRP, which can used for the packaging of pharmaceutical products. CRP deprived children to have access of medicated packaging system, which resulted in devoid of any poisonous effect to the children.


Child-resistant packaging (CRP) Strip packaging Re-closable packaging 



Authors are very much thankful to Anand Pharmacy College for technical assistance and extending facility for successful execution of this project. Thankful to Student Start-up and Innovation Policy for sponsoring the research work. In addition, thank all the volunteers who participated and facilitated the survey part of this study.

Supplementary material

41783_2019_72_MOESM1_ESM.docx (272 kb)
Supplementary material 1 (DOCX 272 kb)
41783_2019_72_MOESM2_ESM.pdf (473 kb)
Supplementary material 2 (PDF 473 kb)
41783_2019_72_MOESM3_ESM.pdf (455 kb)
Supplementary material 3 (PDF 455 kb)


  1. 1.
    World Health Organization technical report series (2002) Guidelines on packaging for pharmaceutical products, vol 902, pp 1–38. Accessed 23 June 2018
  2. 2.
    Center for Biologics Evaluation and Research (2017) Child-resistant packaging statements in drug product labeling. Guidance for industry, United States department of health and human services. Food Drug Adm 8:1–10. Accessed 24 June 2018
  3. 3.
    Center for Drug Evaluation and Research (1999) Container closure systems for packaging human drugs and biologics. United States department of health and human services. Food Drug Adm 5:2–56.
  4. 4.
    Luciano S (2010) Child-resistant packaging offering safety, security, and convenience. Int Pharm Ind 118–120. Accessed 30 June 2018
  5. 5.
    Medicines and Healthcare Products Regulatory Agency (2014) Medicines: packaging, labeling, and patient information leaflets. Accessed 23 May 2017
  6. 6.
    Richardson LA, Abram AK (2017) Child-resistant packaging statements in drug product labeling; Draft guidance for industry. Food Drug Adm 82(148):35–36Google Scholar
  7. 7.
    Kavinda CD, Shaluka FJ, Chamilka YJ (2017) Risk factors for acute unintentional poisoning among children aged 1–5 years in the rural community of Sri Lanka. Int J Pediatr. CrossRefGoogle Scholar
  8. 8.
    Du NT, Due B, Due P (2001) Epidemiology of acute poisonings in Vietnam. Clin Toxicol 39:527–528Google Scholar
  9. 9.
    Malhotra S, Arora RK, Singh B, Gakhar U, Tonk R (2013) Child resistant packaging: a prime concern for packaging of medical products. Int J Pharm Sci Rev Res 22(2):79–88Google Scholar
  10. 10.
    US Consumer Product Safety Commission (2005) Poison prevention packaging: a guide for healthcare professionals, pp 1–23. Accessed 2 July 2018
  11. 11.
    BSI Group (2017) Child resistant packaging: a consumer’s guide to the standards for child resistant packaging. Accessed 13 Dec 2017
  12. 12.
    Testing Procedure for Special Packaging (2019) Electronic code of federal regulations, e-CFR data 16 CFR § 1700.20. Accessed 14 July 2019
  13. 13.
    Poison Prevention Packaging Act of 1970 regulations, 16 CFR § 1700.20—testing procedure for special packaging. Legal Information Institute. Accessed 14 July 2019
  14. 14.
    Child-Resistant Packaging Statements in Drug Product Labeling Guidance for Industry (2017) U.S. Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). . Accessed 15 July 2019
  15. 15.
    Child resistant packaging-requirements and testing procedures for reclosable packages (2004) BS EN ISO 8317:2004. Accessed 18 Sept 2018
  16. 16.
    Child-resistant non-reclosable packaging for pharmaceutical products-requirements and testing (2003) BS EN 14375:2003. Accessed 3 Jan 2019
  17. 17.
    Packaging-child resistant packaging-requirements and testing procedures for non-reclosable packages for non-pharmaceutical products (2005) BS EN 862:2005. Accessed 4 Jan 2019
  18. 18.
    World report on child injury prevention (2008) World health organization/UNICEF. Accessed 4 Jan 2019
  19. 19.
    Packaging-child resistant packaging-Mechanical test methods for reclosable child resistant packaging systems (2012) BS EN ISO 13127:2012. Accessed 8 Feb 2019
  20. 20.
    Gaunt MJ (2007) Child-resistant does not mean childproof. Pharm Times 28–30. Accessed 3 Mar 2019
  21. 21.
    Schwebel DC (2017) Unintentional child poisoning risk: a review of causal factors and prevention studies. Child Health Care 46(2):109–130CrossRefGoogle Scholar
  22. 22.
    Bix L, De La Fuente J, Pimple KD, Kou E (2009) Is the test of senior friendly/child resistant packaging ethical? Health Expect 12(2):430–437. CrossRefGoogle Scholar

Copyright information

© Indian Institute of Packaging 2019

Authors and Affiliations

  1. 1.Department of Pharmaceutics, Faculty of PharmacyMarwadi UniversityRajkotIndia
  2. 2.Department of PharmaceuticsAnand Pharmacy CollegeAnandIndia

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