1 |
N. Sharma, S.S. Rao, A.M. Reddy, "A novel and rapid validated stability-indicating UPLC method of related substances for dorzolamide hydrochloride and timolol maleate in ophthalmic dosage form", J. Chromatogr. Sci, 50(9), 745-755, 2012. DOI: https://doi.org/10.1093/chromsci/bms025
DOI
|
2 |
S.P. Kulkarni, P.D. Amin, "Stability indicating HPTLC determination of timolol maleate as bulk drug and in pharmaceutical preparations", J. Pharm. Biomed. Anal, 23(6), 983-987, 2000. DOI: https://doi.org/10.1016/S0731-7085(00)00389-7
DOI
|
3 |
C. Rundfeldt, "Drug Development-A case study based insight into modern strategies (D. Mars, M. Birkhoff, "Multi-Dose Container for Nasal and Ophthalmic Drugs: A Preservative Free Future?)", Aptar Pharma, Consumer Healthcare Division, Germany, 509-524, 2011.
|
4 |
EZ-DRUG (https://ezdrug.mfds.go.kr/)
|
5 |
Korea consumer agency, "Analysis report of misuse eye-drop from misidentification of eye-drop", Korea, 2018 (http://www.kca.go.kr/brd/m_46/list.do)
|
6 |
K.H. Kim, J.R. Oh, J.H. Kim, H.M. Kim, "Bacteria-Filtering Effect of a Filtering System Used in Eye Drops", J Korean Ophthalmol Soc, 48(10), 1329-1334, 2007. DOI: https://doi.org/10.3341/jkos.2007.48.10.1329
DOI
|
7 |
B. Teuchner, J. Wagner, N.E. Bechrakis, D.O. Holler, M. Nagl, "Microbial Contamination of Glaucoma Eyedrops Used by Patients Compared With Ocular Medications Used in the Hospital", Journal Medicine, 94(8), 583-588, 2015 DOI: https://doi.org/10.1097/MD.0000000000000583
DOI
|
8 |
D.P. Freeman, M.Y. Kahook, "Preservatives in topical ophthalmic medications: historical and clinical perspectives", Expert Rev Ophthalmol, 4(1), 59-64, 2009. DOI: https://doi.org/10.1586/17469899.4.1.59
DOI
|
9 |
A. Tsegaw, T. Abula, Y. Assefa, "Bacterial Contamination of Multi-dose Eye Drops at Ophthalmology Department, University of Gondar, Northwest Ethiopia", Middle East Afr J Ophthalmol, 24(2), 81-86, 2017. DOI: https://doi.org/10.4103/meajo.MEAJO_308_16
DOI
|
10 |
Regulation on Pharmaceuticals Approval, Nortification and Review, MFDS, 2017.
|
11 |
R.B. Matthews, "Regulatory Aspects of Stability Testing in Europe", Drug Dev. Ind. Pharm, 25, 831-856, 1999. DOI: https://doi.org/10.1081/DDC-100102245
DOI
|
12 |
Danijela A. Kostic, Snezana S. Mitic, Danijela C. Naskovic, Aleksandra R. Zarubica, and Milan N. Mitic "Determination of Benzalkonium Chloride in Nasal Drops by High-Performance Liquid Chromatography", E-Journal of Chemistry, Volume 9, Issue 3, Pages 1599-1604, 2012. DOI: https://dx.doi.org/10.1155/2012/172070
DOI
|
13 |
L.M Jurkic, M. Buratovic, I. Valentic, D. Stanfel, "UHPLC study on the degradation profiles of olopatadine hydrochloride in eye drops subjected to heat and filtration methods of sterilisation", Chromatographia, 77, pp. 1067-1080, 2014. DOI: https://doi.org/10.1007/s10337-014-2712-y
DOI
|
14 |
Maha A. Hegazy, May H. Abdelwahab, Hassan A.M.Mendawy, Soheir A. Weshahy, Samah S. A bbas, "Validated HPTLC and HPLC methods for determination of fluorometholone and sodium crmoglycate in presence of their impurities and degradation products; application to kinetic study and on rabbit aqueous humor". J. Liquid chromatography & related technologies, 41(5), pp. 203-222, 2018. DOI: https://doi.org/10.1080/10826076.2018.1431926
DOI
|
15 |
Harry Brittain, "Analytical profiles of drug substancs and excipients 26th", Academic press, 1999.
|
16 |
MFDS(Ministry of Food and Drug Safety), "The Korean Pharmacopoeia (KP11)" [Annex 2], 6.1 ophthalmic solutions, Korea, 2018.
|
17 |
U.S. Pharmacopoeia National Formulary, USP General Chapters: <795> Pharmaceutical Compounding-Non sterile Preparations.
|
18 |
U.S. Pharmacopoeia National Formulary, USP General Chapters: <797> Pharmaceutical Compounding-sterile Preparations.
|
19 |
U.S. Pharmacopoeia National Formulary, USP General notice and requirements.
|
20 |
B.R. Matthews, G.M. Wall, "Stability Storage and Testing of Ophthalmic Products for Global Registration", Drug Dev. Ind. Pharm, 26(12), 1227-1237, 2000. DOI: https://doi.org/10.1081/DDC-100102304
DOI
|
21 |
S.D. Han, C.K. Kim, "Comparative Study on the Stability of Amoxicillin, Clavulanic Acid and its Commercial Combination Products", J. Pharm. Soc. Korea, 49(5), 392-398, 2005.
|
22 |
Guideline on Stability Testing for Pharmaceuticals after Opening, MFDS, 2016.
|
23 |
Shu Chiao Lin, Chin Fen Huang, Li Jiuan Shen, Hsueh Ju Wang, Chia Yu Lin, Fe Lin lin wu, "Formulation and stability of an extemporaneous 0.02% chlohexidine digluconate ophthalmic solution". Journal of the Formosan Medical Association, 2015; 114: 1162-1169, 2015. DOI: https://doi.org/10.1016/j.jfma.2014.08.003
|
24 |
M.J. Park, N.H. Joeng, "Stability evaluation of cefaclor dry syrup after opening with simulation design", J Oil Chemists Soc. Korea, 2017(3): 151-152, 2017.
|
25 |
Note for guidance on in-use stability testing of human medicinal products, EMA, 2001.
|
26 |
S. Bajaj, D. Signla, N. Sakhuja, "Stability Testing of Pharmaceutical Products", Journal of Applied Pharmaceutical Science, 02(03), 129-138, 2012.
|
27 |
R.T. Magari, E. Afonina, "In-use stability modeling", J. Pharm. Biomed. Anal, 56, 799-803, 2011. DOI: https://doi.org/10.1016/j.jpba.2011.07.004
DOI
|
28 |
B. Kommanaboyina, C.T. Rhodes, "Trends in Stability Testing, with Emphasis on Stability During Distribution and Storage", Drug Dev. Ind. Pharm, 25, 857-867, 1999. DOI: https://doi.org/10.1081/DDC-100102246
DOI
|
29 |
G.T. Kulkarni, G. Kuppusamy, B. Suresh, "Stability testing of pharmaceutical products: An overview", Indian J. Pharm. Educ, 38(4), 194-202, 2004.
|
30 |
K.C. Waterman, L. Chen, P. Waterman, B.C. Macdonald, A.P. Monahan, G. Scrivens, "Modeling of in-use stability for tablets and powders in bottles", Drug Dev. Ind. Pharm, 42(10), 1571-1578, 2016. DOI: https://doi.org/10.3109/03639045.2016.1153648
DOI
|
31 |
Y.H. Lee, "Microbial Contamination of Topical Eye Drugs", J Korean ophthalmol Soc. 37(5), 879-886, 1996.
|
32 |
N.R. Woo, N.J. Lee, S.J. Lee, M.Y. Kim, M.J. Park, J.P. Lee, W. Shin, "In-use Stability Study of Phloroglucinol and Nitroglycerin Sublingual Tablets Using Simulation Design after Opening of their Containers", Korean Journal of Pharm society, 61(6), pp. 281-285, 2017. DOI: https://doi.org/10.17480/psk.2017.61.6.281
|
33 |
E.Y. Tu, M.E. Shoff, W. Gao, C.E. Joslin, "Effect of low concentrations of benzalkonium chloride on acanthamoebal survival and its potential impact on empirical therapy of infectious keratitis", JAMA Ophthalmol, 131(5), 595-600, 2013. DOI: https://doi.org/10.1001/jamaophthalmol.2013.1644
DOI
|
34 |
M.Q. Rahman, D. Tejwani, J.A. Wilson, I. Butcher, K. Ramaesh, "Microbial contamination of preservative free eye drops in multiple application containers", Br. J. Ophthalmol, 90(2), 139-141, 2006. DOI: https://doi.org/10.1136/bjo.2005.078386
DOI
|