DocumentsDate added
Original article
Hamoud Khalid Alshaya1,Saleh Ahmed Alogla1,Khalid Sukhail G. Alshammari1,Carlo L. Nazareno2, Mohammad AbdulazizSaud AlJameel2,Ashfaque Hossain1,2*
1 College of Medicine, University of Hail,Hail, Saudi Arabia
2 Center for Molecular Diagnostics and Personalised Therapeutics, University of Hail, Hail, Saudi Arabia
Address reprint requests to
*Ashfaque Hossain, PhD, Department of Microbiology, College of Medicine, University of Hail, Hail, Saudi Arabia
Article citation: Alshaya HK, Alogla SA, Alshammari KSG, Nazareno CL, AlJameel MAS, Hossain A. Isolation and characterisation of bacterial species from patients with dental caries and caries-free subjects. J Pharm Biomed Sci 2016;06(05):333–337.Available at www.jpbms.info
ABSTRACT
Background The oral cavity harbours a large number of bacterial species as normal flora existing as biofilm. Dental disease such as dental caries results when there is a shift in the balance of bacteria towards pathogenic species within these biofilms.
Objective The objective of this study was to isolation, identification and characterisation of oral bacterial species of patients with dental caries and caries-free healthy control subjects.
Materials and Methods A standard bacteriological procedures were followed in the isolation of bacteria. The identification of bacteria was carried out using matrix-associated laser desorption ionisation–time of flight–mass spectrometry (MALDI–TOF–MS) (Bruker MALDI Biotyper system). The characterisation of bacteria involved in the determination of biofilm forming potential and assessment of synergistic antimicrobial action of manuka honey and gentamicin against the oral species.
Results A total of 13 bacterial species were isolated from 35 orals samples (10 from patients with dental caries); of which seven bacterial species have been isolated for the first time in Saudi Arabia. The Streptococcus spp. exhibited varied biofilm-forming potential and response to synergistic antimicrobial activity of manuka honey and gentamicin.
Conclusion The isolation of seven bacterial species for the first time from dental caries and caries-free subjects in Saudi Arabia warrants a larger prevalence study involving molecular and phenotypic tests to assess their role in health and disease in Saudi population.
KEYWORDS dental caries, biofilm, oral microbiology, streptococcus, gentamicin, MALDI–TOF–MS
Acknowledgments: This study was supported by a grant from the Dean ship of Scientific Research, University of Hail to Dr.Ashfaque Hossain.
REFERENCES
1.Li X, Kolltveit KM, Tronstad L, Olsen I. Systemic diseases caused by oral infection. Clin Microbiol Rev. 2000;13:547–558.
2.Donlan RM, Costerton JW. Biofilms: survival mechanisms of clinically relevant microorganisms. Clin Microbiol Rev. 2002;15:167–193.
3.Samaranayake LP. Normal oral flora, the oral ecosystem and plaque biofilm: essential microbiology for dentistry. Elsevier: Philadelphia; 2006. pp. 255–266.
4.Marsh PD. Dental plaque as a biofilm and a microbial community:implications for health and disease. BMC Oral Health. 2006;6:S14.
5.Mendelson MH, Gurtman A, Szabo S, Neibart E, Meyers BR,Policar M, et al. Pseudomonas aeruginosa bacteremia in patients with AIDS. Clin Infect Dis. 1994;18:886–895.
6.Deep A, Chaudhary U, Gupta V. Quorum sensing and bacterial pathogenicity: from molecules to disease. J Lab Physicians.2011;3:4–11.
7.Rahal JJ. Novel antibiotic combinations against infections with almost completely resistant Pseudomonas aeruginosa and Acinetobacter species. Clin Infect Dis. 2006;43:S95–S99.
8.Karayil S, Deshpande SD, Koppikar GV. Effect of honey on multidrugresistant organisms and its synergistic action with three common antibiotics. J Postgrad Med. 1998;44:93–96.
9.Al-Jabri AA, Al-Hosni SA, Nzeako BC. Antibacterial activity of Omanihoney alone and in combination with gentamicin. Saudi Med J. 2005;26:767–771.
10.Mukherjee S, Chaki S, Das S, Sen S, Dutta SK, Dastidar SG. Distinct synergistic action of piperacillin and methylglyoxal against Pseudomonas aeruginosa. Indian J. Exp. Biol. 2011; 49: 547–51.
11.Jenkins RE, Cooper RA. Synergy between oxacillin and manuka honey sensitizes methicillin-resistant Staphylococcus aureus to oxacillin. J AntimicrobChemother. 2012;67:1405–1407.
12.van Veen SQ, Claas ECJ, Kuijper EdJ. High-throughput identification of bacteria and yeast by matrix-assisted laser desorption ionization- time of flight mass spectrometry in conventional medical microbiology laboratories. J Clin Microbiol. 2010;48:900–907.
13.Wieser A, Schneider L, Jung J, Schubert S. MALDI–TOF–MS in microbiological diagnostics: identification and beyond. J Appl Biotechnol. 2010;93:965–974.
14.Moskowitz SM, Foster JM, Emerson J, Burns JL. Clinically feasible biofilm susceptibility assay for isolates of Pseudomonas aeruginosa from patients with cystic fibrosis. J Clin Microbiol. 2004;42:1915–1922.
15.Pilhstrom BL, Michalowicz BS, Johnson NW. Periodontal diseases.Lancet. 2005;366:1809–1820.
16.Selwitz RH, Ismail AI, Pitts NB. Dental caries. Lancet. 2007;369:51–59.
17.Zaura E, Keijser BJ, Huse SM, Crielaard W. Defining the healthy core microbiome of oral microbial communities. BMC Microbiol.2009;9:259.
18.Bik EM, Long CD, Armitage GC, Loomer P, Emerson J, Mongodin EF, et al. Bacterial diversity in the oral cavity of 10 healthy individuals.ISME J. 2010;4:962–974.
19.Amoroso P, de Ávila FA, Gagliardi CMO. Prevalence of different Streptococci species in the oral cavity of children and adolescents. Braz J Oral Sci. 2003;2:164–168.
20.Gross EL, Beall CJ, Kutsch SR, Firestone ND, Leys EJ, Griffen AL.Beyond Streptococcus mutans: dental caries onset linked to multiple species by 16S rRNA community analysis. PLoS ONE.2012;7:e47722.
21.Thurnheer T, Gmur R, Giertsen E, Guggenheim B. Automated fluorescent in situ hybridization for the specific detection and quantification of oral streptococci in dental plaque. J Microbiol Methods. 2001;44:39–47.
22.Sanchez MC, Llama-Palacios A, Blanc V, Leo´n R, Herrera D, Sanz M. Structure, viability and bacterial kinetics of an in vitro biofilm model using six bacteria from the subgingival microbiota.J Periodont Res. 2011;46:252–260.
23.Wecke J, Kersten T, Madela K, Moter A, Gobel UB, Friedmann A, et al. A novel technique for monitoring the development of bacterial biofilms in human periodontal pockets. FEMS Microbiol Lett. 2000;191:95–101.
24.Khan ST, Ahmad J, Ahamed M, Musarrat J, Al-Khedhairy AA. Zinc oxide and titanium dioxide nanoparticles induce oxidative stress, inhibit growth, and attenuate biofilm formation activity of Streptococcus mitis. J Biol Inorg Chem. 2016;21(3):295–303.
Statement of originality of work: The manuscript has been read and approved by all the authors. The requirements for authorship have been met, and that each author believes that the manuscript represents honest and original work.
Competing interest / Conflict of interest: The author(s) have no competing interests for financial support, publication of this research, patents, and royalties through this collaborative research. All authors were equally involved in discussed research work. There is no financial conflict with the subject matter discussed in the manuscript.
Disclaimer: Any views expressed in this paper are those of the authors and do not reflect the official policy or position of the Department of Defense.
Review article
Supriya S. Shidhaye,Bhagyashri Surendra Parab*,Ruchi Singh
Department of Pharmaceutics, Vivekanand Education Society’s College of Pharmacy,
Chembur, Mumbai, India
Address reprint requests to
*Ms. Bhgayashri Surendra Parab,
3/304, Indraprastha Bldg., Opp. Jai Hind Talkies, Lalbaug, Mumbai, 400012, India
Article citation: Shidhaye SS, Parab BS,Singh R. Current trends in biosimilars. J Pharm Biomed Sci 2016;06(05):286–292.Available at www.jpbms.info
ABSTRACT
Recombinant technology has brought a wide availability of the treatment options for many life-threatening diseases. Consistent with the great inventions in the area of biotechnology, biopharmaceuticals have become the fastest growing area of the pharmaceutical industry.
The recent expiration of many innovator biopharmaceutical products has triggered the development of alternate versions of originators biologic drugs. Unlike generic drugs, these new biological products are not the identical copies of innovator products. Thus, these alternate versions are referred to as ‘follow-on biologics’ or ‘biosimilar drugs’. Slight changes in starting materials or modification in the manufacturing processes have significant impact on the final structure of the biologic molecule. Thus, the exact structure of the originator’s biologic molecule cannot be duplicated. This makes these biosimilars very unique molecules necessitating the need for elaborate characterisation and consistent pharmacovigilance.
KEYWORDS recombinant technology, biosimilars, biopharmaceutical products
REFERENCES
1.Schellekens H. Biosimilar therapeutics: what do we need to consider? NDT Plus. 2009;2:i27–i36.
2.Mishra M. Biosimilars: current perspectives and future implications. Indian J Pharmacol. 2012;44(1):12–14.
3.Biosimilar medicines. London: European Medicines Agency. 2016. Available at: www.ema.europa.eu
4.Biosimilars. Silver Spring, MD: U.S. Food and Drug Administration.2016. Available at: www.fda.gov
5.Evaluation of Biosimilars. Woden: Therapeutic Goods Administration,Department of Health and Ageing, Australian Government. 2016. Available at: www.tga.gov.au
6.Singh B, Saluja SV. Biosimilars: an overview. Biosimilars. 2011;1:1–11, Dovepress.
7.Hinderer W. Biogeneric drugs. In: Kayser O, Muller RH, (eds):Pharmaceutical biotechnology, drug discovery and clinical applications. !!HYPERLINK “http://www.pharmatechbd.blogspot.com/” Pharmatech; 2013. pp. 119–144.
8.Lipp R, Pungor E. Formulation of biotech products. In: Kayser O,Müller RH (eds). Pharmaceutical biotechnology: drug discovery and clinical applications. Weinheim: Wiley-VCH Verlag GmbH & Co. KGaA. 2004. pp. 173–185.
9.Resnik DB. Patents in pharmaceutical industry: legal and ethical issues. In: Kayser O, Müller RH (eds). Pharmaceutical biotechnology:drug discovery and clinical applications. Weinheim: Wiley- VCH Verlag GmbH & Co. KGaA. 2004. pp. 187–199.
10.Walsh G. Drug Approval in the European Union and the United States. In: Kayser O, Müller RH (eds). Pharmaceutical biotechnology:drug discovery and clinical applications. Weinheim: Wiley-VCH Verlag GmbH & Co. KGaA. 2004. pp. 201–210.
11.Singh BD. Animal tissue culture and hybridoma technology.In: Biotechnology: expanding horizons. New Delhi: Kalyani Publishers. 2008. pp. 207–233.
12.Watson JD, Gilman M. Recombinant DNA in medicine and industry, 2nd ed., In: Recombinant DNA. New York: Scientific American Books. 1992. pp. 462–468.
13.Abrams JS, Chretien I, Lee FD, Pearce MK. Monoclonal antibodies against human interleukin-4 and hybridomas producing the same. USA: Schering Biotech Corp. European Patent Register.
14.Rgen JJ, Brange V, Havelund S. Insulin analouges. European Patent Register.
15.Mellstedt H, Niederwieser D, Ludwig H. The challenge of biosimilars.Ann Oncol. 2008;19:411–419.
16.Rane SS, Diwan N, Narayan O, Mody R. Developing robust approaches to the effective characterization of biosimilars. Available at: www.pharmafocusasia.com
17.World’s first biosimilar antibody approved in India, July 23, 2012.Available at: www.biosimilarnews.com
18.Biosimilar medicinal products: what do you need to know about? A Consensus Information Document, European Commission.
19.Wiecek A, Mikhail A. European regulatory guidelines for biosimilars. Nephrol Dial Transplant. 2006;21(5):v17–v20.
20.Developing biosimilars in emerging markets: regulatory and clinical considerations. White paper ppdi.com. 2013.
Original Article
Linda Yulianti1*, Kusmarinah Bramono2,Etik Mardliyati3, Hans-Joachim Freisleben4,5
1 Biomedical Sciences Doctoral Program, Faculty of Medicine, University of Indonesia,Salemba Jakarta, Indonesia
2 Department of Dermatovenerology, Faculty of Medicine, University of Indonesia,Salemba Jakarta, Indonesia
3 Centre for Pharmaceutical and Medical Technology, Agency for the Assessment and Application of Technology,
4 Medical Research Unit, Faculty of Medicine, University of Indonesia, Salemba Jakarta, Indonesia
5 German–Indonesian Medical Association(DIGM e. V.)
Address reprint requests to:
*Dr. Linda Yulianti, MD, Biomedical Sciences Doctoral Program, Faculty of Medicine, University of Indonesia,Salemba Jakarta, Indonesia
Article citation: Yulianti L, Bramono K, Mardliyati E, Freisleben HJ. Effects of Centella asiatica ethanolic extract encapsulated in chitosan nanoparticles on proliferation activity of skin fibroblasts and keratinocytes, type I and III collagen synthesis and aquaporin 3 expression in vitro. J Pharm Biomed Sci 2016;06(05):315–327.Available at www.jpbms.info
ABSTRACT
Background The activity of skin cell proliferation, collagen synthesis and skin hydration decrease with the process of aging; therefore, the skin looks dull, dry and sagging.
Aquaporin 3 (AQP3) is a key protein that plays a major role in skin cell proliferation and skin hydration. Retinoic acid (RA) is still considered for anti-aging treatment, but it frequently shows side effects, such as skin irritation. Centella asiatica (CA) formulation in chitosan nanoparticles has a promising potential as anti-aging cosmetic.
Aim The aim of this study was to evaluate the effects of CA ethanolic extract encapsulated in chitosan nanoparticles (CAEE + CNP) on skin cell proliferation, collagen synthesis and AQP3 expression in vitro, when compared to RA.
Methods Microculture tetrazolium assay was conducted to analyse the proliferation of normal human dermal fibroblasts (NHDF) and normal human epidermal keratinocytes (NHEK) at 24, 48 and 72 h. Type I and III collagen synthesis was evaluated at the same time points using ELISA. Aquaporin 3 expression at 24 h was evaluated using immunocytochemistry and measured quantitatively using ImageJ software. All treatments involved several concentrations of CAEE + CNP and RA through serial dilution.
Results Collagen type I and III synthesis of NHDF and NHEK was neither significantly different from untreated controls nor from RA-treated cells. Nevertheless, CAEE + CNP
stimulated the proliferation of both NHDF and NHEK. Additionally, AQP3 expression in both cell types was upregulated by CAEE + CNP.
Conclusion CAEE + CNP is a promising formulation for anti-aging activity by inducing skin cell proliferation and AQP3 expression. The clinical trials are still needed to evaluate skin hydration in vivo.
Keywords aquaporin 3, Centella asiatica, chitosan nanoparticles, collagen, fibroblasts,hydration, keratinocytes, proliferation
References
1.Guillou MJ, Bordes S, Soulie C, Closs B. Stimulation of dermal and epidermal metabolism: an approach to antiaging. Cosmet Toiletries. 2005;120(6):97–102.
2.Baumann L. Skin ageing and its treatment. J Pathol. 2007;211:241–251.
3.Yaar M. Clinical and histological features of intrinsic versus extrinsic skin aging. In: Gilchrest B, Krutmann J, (eds): Skin aging. Berlin: Springer. 2006. pp. 9–21.
4.Zouboulis CC, Makrantonaki E. Clinical aspects and molecular diagnostics of skin aging. Clin Dermatol. 2011;29(1):3–14.
5.Rittie L, Fisher GJ, Voorhess JJ. Retinoid therapy for photoaging. In: Gilchrest B, Krutmann J, (eds): Skin aging. Berlin: Springer.2006. pp. 143–156.
6.Rawlin AV. Retinoids and retinoic acid treatment of skin aging.In: Rhein LD, Fluhr JW, (eds): Aging skin: current and future therapeutic strategies. USA: Allured Books. 2010. pp. 219–234.
7.Menta RC, Fitzpatrick RE. Growth factors and aging skin treatment.In: Rhein LD, Fluhr JW, (eds): Aging skin: current and future therapeutic strategies. USA: Allured Books. 2010. pp. 495–512.
8.Draelos ZD. New delivery systems for novel compounds. In:Sadrick NS, Lup M, Berso DS, Draelus ZD, (eds): Cosmet Sci. 2008. pp. 32–39.
9.Pereda MC, Dieamant GC, Eberlinc S, Werkac RM, Colombic D, Queiroz ML, et al. Expression of differential genes involved in the maintenance of water balance in human skin by Piptadenia colubrina extract. J Cosmet Dermatol. 2010;9(1):35–43.
10.Sirisa-ard P, Charumanee S, Rahuruk N, Inchai N, Pholsongkram K. Development of Centella asiatica (Linn.) urban silicone transdermal patch for wound healing. J Metals Mater Miner. 2010;20(3):169–171.
11.Bhavna D, Jyoti K. Centella asiatica: the elixir of life. Int J Res Ayurveda Pharm. 2011;2(2):431–438.
12.Gohil KJ, Patel JA, Gajjar AK. Pharmacological review on Centella asiatica: a potential herbal cure-all. Indian J Pharm Sci. 2010;72(5):546–556.
13.Zainol NA, Voo SC, Sarmidi MR, Aziz RA. Profiling of Centella asiatica(L.) urban extract. Malaysian J Anal Sci. 2008;12(2):322–327.
14.Chanchal D, Swarnlata S. Novel approaches in herbal cosmetics.J Cosmet Dermatol. 2008;7(2):89–95.
15.Pittella F, Dutra RC, Junior DD, Lopes MTP, Barbosa NR. Antioxidant and cytotoxic activities of Centella asiatica (L) Urb. Int J Mol Sci. 2009;10(9):3713–3721.
16.Paocharoen V. The efficacy and side effect of oral Centella asiatica extract for wound healing promotion in diabetic wound patients. J Med Assoc Thail. 2010;93(7):166–170.
17.Okonogi S, Sirithunyalug J, Chen Y. Nano-encapsulation of Centella asiatica, bioactive extract. Paper presented at the XVIth International conference on bioencapsulation, Dublin, Ireland. 2008.
18.Morganti P, Fabrizi G, Palombo P, Ruocco E, Morganti G, Cardilo A. Chitin-nanofibrils: a new active cosmetic carrier. J Appl Cosmetol. 2008;26(3):113–128.
19.Morganti P, Carezzi F, Ciotto PD. Chitin nanoparticles as innovative delivery system. Person Care. 2012;5(2):55–58.
20.Morganti P, Morganti G, Muzzarelli RAA, Muzzarelli C. Chitin nanofibrils: a natural compound for innovative cosmeceuticals. In: Anthony J, O’Lenick JR, (eds): Natural and organics in cosmetics: trends and technology. USA: Allured Books. 2010. pp. 383–393.
21.Cao Z, Mo X, Zhang K, Fan Y, Lin A, He C, et al. Fabrication of chitosan or silk fibro in composite nanofibers for wound-chessing applications. Int J Mol Sci. 2010;11(9):3529–3539.
22.Howling GI, Dettmar PW, Goddard PW, Hampson FC, Dornish M, Wood EJ. The effect of chitin and chitosan on the proliferation of human skin fibroblast and keratinocytes in vitro. Biomaterials. 2001;22(22):2959–2966.
23.Leonida M. Nano-sizing chitosan for wound healing, anti-aging.Cosmet Toiletries. 2012;127(7):532.
24.Nasir A. Nanotechnology and dermatology: part 1: potential of nanotechnology. Clin Dermatol. 2010;28(4):458–466.
25.Moddaresi M, Tamburic S, Williams S, Jones SA, Zhao Y, Brown MB. Effects of lipid nanocarriers on the performance of topical vehicles in vivo. J Cosmet Dermatol. 2009;8(2):136–143.
26.Wiesenthal A, Hunter L, Wang S, Wickliffe J, Wilkerson M. Nanoparticles: small and mighty. Int J Dermatol. 2011;50(3):247–254.
27.Tiyaboonchai W. Chitosan nanoparticles: a promising system for drug delivery. Naresuan Univ J. 2003;11(3):51–66.
28.Wang X, Chi N, Tang X. Preparation of estradiol chitosan nanoparticles for improving nasal absorption and brain targeting. Eur J Pharm Biopharm. 2008;70(3):735–740.
29.Draelos Z. Aquaporins: an introduction to a key factor in the mechanism of skin hydration. J Clin Aesthet Dermatol. 2012;5(7):53–56.
30.Hara-Chikuma M, Verkman AS. Roles of aquaporin-3 in the epidermis. J Invest Dermatol. 2008;128(9):2145–2151.
31.Verkman AS. A cautionary note on cosmetics containing ingredients that increase aquaporin 3 expression. Exp Dermatol. 2008;17(10):871–872.
32.Jurzak M, Latocha M, Goiniczek K, Kapral M, Garncarczyk A, Pierzchala E. Influence of retinoids on skin fibroblasts metabolism in vitro. Acta Pol Pharm. 2008;65(1):85–91.
33.Bellemère G, Von Stetten O, Oddos T. Retinoic acid increases aquaporin 3 expression in normal human skin. J Invest Dermatol. 2008;128(3):542–548.
34.Fan W, Yan W, Xu Z, Ni H. Formation mechanism of monodisperse, low molecular weight chitosan nanoparticles by ionic gelation technique. Colloids Surf B Biointerfaces. 2012;90:21–27.
35.Varani J, Shayevitz J, Perry D, Mitra RS, Nickoloff BJ, Voorhees JJ. Retinoic acid stimulation of human dermal fibroblast proliferation is dependent on suboptimal extracellular Ca2+ concentration. Am J Pathol. 1990;136(6):1275–1281.
36.Hamid AA, Shah ZM, Muse R, Mohamed S. Characterization of antioxidative activity of various extracts of Centella asiatica (L) urban. Food Chem. 2002;77(4):465–469.
37.Wu F, Bian D, Xia Y, Gong Z, Tan Q, Chen J, et al. Identification of major active ingredients responsible for burn wound healing of Centella asiatica herbs. Evid Based Complementary Altern Med. 2012;2012:13.
38.Song J, Dai Y, Bian D, Zhang H, Xu X, Xia Y, et al. Madecassoside induces apoptosis of keloid fibroblasts via a mitochondrial-dependent pathway. Drug Dev Res. 2011;72(4):315–22.
39.Lu L, Ying K, Wei S, Fang Y, Liu Y, Lin H, et al. Asiaticoside induction for cell-cycle progression, proliferation and collagen synthesis in human dermal fibroblasts. Int J Dermatol. 2004; 43(11):801–807.
40.Lee JH, Kim HL, Lee MH, You KE, Kwon BJ, Seo HJ, et al. Asiaticoside enhances normal human skin cell migration, attachment, and growth in vitro wound healing model. Phytomedicine. 2012;19(13):1223–1227.
41.Daly TJ, Weston WL. Retinoic effect on fibroblast proliferation and collagen synthesis in vitro and on fibrotic disease in vivo. J Am Acad Dermatol. 1986;4(2):900–902.
42.Shigematsu T, Tajima S. Modulation of collagen synthesis and cell proliferation by retinoids in human skin fibroblasts. J Dermatol Sci. 1995;9(2):142–145.
43.Hashim P, Sidek H, Helan MHM, Sabery A, Palanisamy UD, Ilham M. Triterpene composition and bioactivities of Centella asiatica. Molecules. 2011;16(2):1310–1222.
44.Jean J, Soucy J, Pouliot R. Effects of retinoic acid on keratinocyte proliferation and differentiation in a psoriatic skin model. Tissue Eng Part A. 2011;17(13–14):1859–1868.
45.Li J, Tang H, Hu X, Chen M, Xie H. Aquaporin 3 gene and protein expression in sun-protected human skin decreases with skin ageing. Aus J Dermatol. 2010;51(2):106–112.
46.Hara-Chikuma M, Verkman AS. Aquaporin 3 facilitates epidermal cell migration and proliferation during wound healing. J Mol Med. 2007;86(2):221–231.
47.Verkman AS. Aquaporins at a glance. J Cell Sci. 2011;124(13):2107–2112.
48.Cao C, Sun Y, Healey S, Bi Z, Hu G, Wan S, et al. EGFR-mediated expression of aquaporin 3 is involved in human skin fibroblast migration. Biochem J. 2006;400:225–234.
49.Ryu HM, Oh EJ, Park SH, Kim CD, Choi JY, Cho JH, et al. Aquaporin 3 expression is up-regulated by TGF-beta1 in rat peritoneal mesothelial cells and plays a role in wound healing. Am J Pathol. 2012;181(6):2047–57.
50.Song X, Xu A, Pan W, Wallin B, Kivlin R, Lu S, et al. Nicotinamideattenuates aquaporin 3 overexpression induced by retinoic acid through inhibition of EGFR/ERK in cultured human skin keratinocytes. Int J Mol Med. 2008;22(2):229–36.
51.Dumas M, Sadick NS, Nobless E, Juan M, Lachmann-Weber N,Boury-Jamot M, et al. Hydrating skin by stimulating biosynthesis of aquaporins. J Drugs Dermatol. 2007;6(6):20–24.
52.Velazquez PMC, Dieamant GC, Eberlin S, Noqueira C, Colombi D, Stasi LCD, et al. Effect of green Coffea arabica L. seed oil on extracellular matrix components and water-channel expression in in vitro and ex vivo human skin models. J Cosmet Dermatol. 2009;8(1):56–62.
Statement of originality of work: The manuscript has been read and approved by all the authors, the requirements for authorship have been met, and that each author believes that the manuscript represents honest and original work.
Source of funding: None.
Acknowledgment: The authors wish to thank Dani, IntanRazari, Ita and Labibah for laboratory assistance and Indra Kusuma for the cell cultures of NHDF and NHEK.
Competing interest / Conflict of interest: The author(s) have no competing interests for financial support, publication of this research, patents and royalties through this collaborative research.
All authors were equally involved in discussed research work. There is no financial conflict with the subject matter discussed in the manuscript.
Disclaimer: Any views expressed in this paper are those of the authors and do not reflect the official policy or position of the Department of Defense.
Original article
Ishraqa Mohamed1, Siham Abdallah2*
1 National Drug Quality Control Laboratory,Khartoum, Sudan
2 Qassium University, Faculty of Pharmacy, Buraydah 52571, Saudi Arabia
Address reprint requests to:
*Siham Abdallah, Qassium University,Faculty of Pharmacy, Buraydah 52571,Saudi Arabia
Article citation: Mohamed I, Abdallah S.Stability of levothyroxine sodium tablets marketed in Sudan. J Pharm Biomed Sci 2016;06(05):328–332. Available at www.jpbms.info
ABSTRACT
Stability of medicinal products is the extent to which a product retains, within specified limits throughout its period of storage and use (i.e. its shelf life), the same properties and characteristics that it possessed at the time of its manufacture.
The aim of this study is to evaluate real-time stability and photo-stability of levothyroxine sodium tablets marketing in Sudan. Levothyroxine sodium tablets from different manufacturers were kept at control room temperature (23–25°C); All the samples were analysed every month using the British Pharmacopoeia (BP) HPLC method.
All tablets were kept in a closed glass dish and exposed to direct sunlight for 10 days to evaluate photo-stability using BP and HPLC methods.
The results revealed that thyroxine tablets had become out of specification (88.0, 87.0 and 87.0%) after 15, 20 and 19 months, respectively, from the date of manufacturing and lost more than 5% from initial concentration after 8–9 months; and lost about 40% of its potency after exposure to sunlight.
The shelf life of levothyroxine sodium dosage form should be <2 years to ensure that the dosage form was containing the correct dose when dispensed for use. It is evident from the analysis, sunlight has measurable effect on the stability of levothyroxine sodium even in solid dosage forms.
REFERENCES
1.World Health Organization. Quality assurance. Quality assurance of pharmaceutical. 2007;2:16.
2.Rockville MD. United State Pharmacopeia, Convention; 2004.
3.Walter L. Pharmaceutical codex. London: Pharmaceutical Press;1994. pp 278–282,284.
4.Becket AH, Stenlake JB. Practical pharmaceutical chemistry;2004. pp (99–112,127,152–155).
5.British Pharmacopeia. The stationery office, levothyroxine sodium,London: British Pharmacopoeia; 2005.
6.Anthony CM, David OM, Widdop B, Galichet LY. Clarke’s analysis of drugs and poisons, 3rd ed., London: Pharmaceutical Press;2004. p 480.
7.Roberts GW. Taking care of thyroxine. Aust Prescr. 2004;27:75–6.
8.Waston DG. Pharmaceutical analysis: a textbook for pharmacy students and pharmaceutical chemists. Edinburgh: Churchill Livingstone. 1999. pp 97–98,207–208,237–238.
9.Federal Register. Vol. 62(157). 1997. pp 43535–43538.
Statement of originality of work: The manuscript has been read and approved by all the authors. The requirements for authorship have been met, and that each author believes that the manuscript represents honest and original work.
Source of funding: None.
Competing interest / Conflict of interest: The author(s) have no competing interests for financial support, publication of this research, patents, and royalties through this collaborative research. All authors were equally involved in discussed research work. There is no financial conflict with the subject matter discussed in the manuscript.
Disclaimer: Any views expressed in this paper are those of the authors and do not reflect the official policy or position of the Department of Defense.
Original Article
Riyaz Ahamed S1*,Subramanya BK2,Prakash SB3,Ansari A4
1 Department of Community Medicine,Koppal Institute of Medical Sciences, KIMS,Koppal, Karnataka, India
2 Department of Pharmacology, Koppal Institute of Medical Sciences, KIMS,Koppal, Karnataka, India
3 Department of Physiology, Koppal Institute of Medical Sciences, KIMS, Koppal,Karnataka, India
4 Department of Community Medicine,J.N.M.C. Aligarh Muslim University, Aligarh,UP, India
Address reprint requests to
*Dr. Riyaz Ahamed S, MD, Assistant Professor, Department of Community Medicine, Koppal Institute of Medical Sciences, District Hospital Campus,Hospet Road, Koppal, Karnataka, India
Article citation: Riyaz SA, SubramanyaBK, Prakash SB, Ansari A. Prevalence of overweight and obesity in urban and rural areas of Aligarh. J Pharm Biomed Sci 2016;06(05):279–283. Available at www.jpbms.info
Background Overweight and obesity are the major risk factors for a number of chronic diseases, including diabetes, cardiovascular diseases and cancer. There is a need to evaluate the burden of obesity in local population using standardised methodology.
Objectives 1. To estimate the prevalence of overweight and obesity in urban and rural areas of Aligarh 2. To correlate the overweight and obesity with sociodemographic factors.
Study Design A community-based study.
Setting Field practice areas of Rural Health Training Centre and Urban Health Training Center, Department of Community Medicine, JNMCH, AMU Aligarh.
Study Period 1 year.
Participants A total of 640 individuals from urban and rural areas were included. Sampling:Systematic random sampling.
Statistical Analysis The data were analysed using SPSS 13, percentages and Chi-square test were used.
Results The prevalence of high body mass index (BMI [overweight + obesity]) in study subjects was 40.4% (≥23 kg/m²) and 22.6% (≥25 kg/m²), respectively, depending upon the criteria used to define high BMI. The prevalence of obesity in the study subjects was 22.6% by Asia-Pacific classification and 5% by WHO classification. The prevalence of high BMI in females was higher as compared to males irrespective of the classification used. The prevalence of overweight was high in individuals belonging to higher SES compared to lower SES.
Conclusion The prevalence of overweight and obesity is showing the increasing trend both in urban and rural areas and calls for obesity preventive management strategies to be harmonised with existing public health policies and programmes for control of all NCDs.
Keywords overweight, obesity, prevalence, abdominal obesity
Statement of originality of work: The manuscript has been read and approved by all the authors, the requirements for authorship have been met, and that each author believes that the manuscript represents honest and original work.
Sources of funding: None.
Competing interest / Conflict of interest:The author(s) have no competing interests for
financial support, publication of this research,patents and royalties through this collaborative
research. All authors were equally involved in discussed research work. There is no financial
conflict with the subject matter discussed in the manuscript.
Disclaimer: Any views expressed in this paper are those of the authors and do not reflect the
official policy or position of the Department of Defense