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Investigation on Adhesion Control Standards and Skin Adverse Effects of Skin Attached Formulations  

Kim, Ji Yeon (Department of Food and Drug, Chosun University Graduate School)
Kim, Kwang Joon (College of Pharmacy, Chosun University)
Park, Sang-Wook (Department of Food and Drug, Chosun University Graduate School)
Bang, Joon Seok (Graduate School of Clinical Pharmacy, Sookmyung Women's University)
Lee, Wonjae (Department of Food and Drug, Chosun University Graduate School)
Publication Information
Korean Journal of Clinical Pharmacy / v.24, no.3, 2014 , pp. 219-228 More about this Journal
Abstract
Objectives: This paper was aimed to investigate the adhesion control standards of pain relieving patch (PRP) drugs and to survey it's adverse effects on the skin of patients for safe use of PRP drugs. Methods: In this study, the related documents of PRP drugs of Korea pharmacopoeia (KP), United States pharmacopoeia (USP), Japanese Pharmacopoeia (JP), European pharmacopoeia (EP), and information web sites of the Ministry of Food and Drug Safety (MFDS) were surveyed. Also, the past and current labeling of PRP drugs marketed in the pharmacy was investigated and compared. Results: In KP and JP, the lower limit standard for PRP's adhesion control is established, but the upper limit standard is not designated. In USP and EP, neither the lower nor upper limit standard is established. The main reasons of skin adverse effects are considered as inherent adverse reactions of the applied drugs for PRP. Another reason is involved in patient's medication mistakes related to PRP's adhesion control, respiratory depression of skin according to physical skin closure, and microbial growth, etc. Conclusion: For safe use of PRP drugs, we proposed ensured guidelines like additional instructions of pharmacist's prescription and detailed labeling systems for usage of PRP drugs applied on skin.
Keywords
pain relieving patch; adhesion control standards; skin adverse effect;
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  • Reference
1 Notice #2014-46, KMFDS 'Korean Pharmacopoeia: General Formulation' http://www. mfds.go.kr/index.do?x=0&searchkey =title:contents&mid=1013&searchword=대한민국약전&y= 0&division=&pageNo=1&seq=6313&cmd=v (Accessed on February 12, 2014).
2 Transdermal formulation, Choi HK, Shinil Books, Seoul, Korea, 1999.
3 Report information by Korea Customer Agency http:// www.kca.go.kr/brd/m_32/view.do?seq=1361&multi_itm_seq=, (Accessed on November 9, 2012).
4 Korea National Institute of Food and Drug Safety Evaluation, "Research on establishing of guidelines for evaluating the effectiveness of drug safety", 2011.
5 Japanese Pharmacopoeia $15^{th}$ edition, Ministry of Health, 2010.
6 United States Pharmacopoeia $34^{th}$ edition, USP Convention, 2011.
7 European Pharmacopoeia 7.0, European Directorate for the Quality of Medicines & Health Care, 2011.
8 EZdrug, Korea Ministry of Food and Drug Safety. http:// ezdrug.mfds.go.kr (Accessed on June, 2014)
9 Notice #2014-46, KMFDS 'Korean Pharmacopoeia: Individual Monograph'. Internet site: http://www.mfds.go.kr/ index.do?x=0&searchkey=title:contents&mid=1013&searchwo rd= 대한민국약전&y=0&division=&pageNo=1&seq=6313 &cmd=v (Accessed on February 12, 2014).
10 Notice #2013-235, KMFD 'Criteria for non-formulary drugs excluding Korean Pharmacopoeia'. Internet site: http://www. mfds.go.kr/index.do?x=0&searchkey= title:contents&mid =1013&searchword=대한민국약전외&y= 0&division=&page No=1&seq=6312&cmd=v (Accessed on November 21, 2013).
11 Notice #2014-58, KMFD 'Regulations for marketing and sales, report, review of authorized medications'. Internet site: http://www.mfds.go.kr/index.do?x=0&searchkey=title: contents&mid=1013&searchword= 의약품의 품목&y=0& division=&pageNo=1&seq=7773&cmd=v (Accessed on February 12, 2014).
12 Notice #2014-77, KMFD 'Standards and test methods on the quasi-drugs'. Internet site: http://www.mfds.go.kr/ index.do?x=0&searchkey=title:contents&mid=1013&search word= 의약외품 &y=0&division=&pageNo=1&seq=7737 &cmd=v (Accessed on February 12, 2014).
13 Drug approval and licensing procedures in Japan 2010.
14 Prez-Caldern R, Gonzalo-Garijo MA, Rodrguez-Nevado I. Generalized allergic contact dermatitis from nitroglycerin in transdermal therapeutic system. Contact Dermatitis 2002;46(5):303.   DOI   ScienceOn
15 Alfaya T, Mur Gimeno P, Iglesias AM, et al. Allergic contact dermatitis caused by an ethinylestradiolnorelgestromin transdermal therapeutic system. Contact Dermatitis 2011;64(4):237-44.   DOI   ScienceOn
16 FDA safety page, drug topics. April 1, 2002. Lee M and Phillips J.
17 Tokumura F, Ohyama K, Fujisawa H, et al. Conformability and irritancy of adhesive tapes on the skin. Contact Dermatitis 1997;37(4):173-78.   DOI   ScienceOn
18 Wokovich AM, Prodduturi S, Doub WH, et al. Transdermal drug delivery system (TDDS) adhesion as a critical safety, efficacy and quality attribute. Eur J Pharm Biopharm 2006;64(1):1-8.   DOI   ScienceOn
19 Cilurzo F, Gennari CG, Minghetti P. Adhesive properties: a critical issue in trans- dermal patch development. Expert opin drug deliv 2012;9(1):33-45.   DOI   ScienceOn
20 Satas D. Handbook of Pressure Sensitive Adhesive Technology, 3rd ed. Rhode Island: Satas & Associates, 1999;36-61.
21 Korea Pharmaceutical Information Center (Accessible at http://www.health.kr)
22 Druginfo, Drug Information Organization in Korea (Accessible at http://www.druginfo.co.kr)