Total quality management of pharmaceutical preparations containing vitamin E

Total quality management of pharmaceutical preparations containing vitamin E

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Title: Total quality management of pharmaceutical preparations containing vitamin E
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Article_Title: Total quality management of pharmaceutical preparations containing vitamin E
Authors: Angela Caunii, Lucretia Udrescu, Zoltan Szabadai , George Pribac , Monica Butnariu
Affiliation: Biochemistry, Exact Sciences Department, Banat’s University of Agricultural Faculty of Pharmacy, University of Medicine and Pharmacy “Victor Babes”, Timisoara, Romania, e–mail: angelacaunii@yahoo.com.
Faculty of Medicine, Pharmacy and Dental Medicine, “Vasile Goldis” Western University, Arad, Romania
Chemistry and Vegetal Sciences and Veterinary Medicine, Timisoara, Romania, e–mail: monicabutnariu@yahoo.com
Abstract: Due to globalization and rapid processes in technology, production’s competitiveness today is increasing. Producers must be permanently alert to find new ways to design, produce, sell and deliver their products. Today, quality is imperative. Even low–cost pharmaceutical products are expected to have a good quality. Degradation over time of many active substances with pharmaceutical interest, is a serious problem both regarding the industrial processes of obtaining, storage and use of these substances. In pharmaceutical practice there are used drugs with advanced photosensitivity; problem of their degradation over time includes the action of light as a factor capable of contributing to their entire degradation. Ultraviolet radiation is not the subject of discussion, given that during the storage and use of therapeutics drugs, they are rarely exposed to this radiation. Otherwise, the near ultraviolet radiation, with the spectral ranges 300–400nm, can be a real threat, especially in hospitals where the natural lighting is replaced by fluorescent tubes radiation. This study aims identification of physic–chemical methods used in total quality management for medicinal products containing retinal acetate (Vitamin E), conditioned as gelatine capsules (pearls).
Keywords: total quality management, gelatin capsules, Vitamin E
References: Sim, C.O. Hamdan, M.R. Ismail, Z. Ahmad, M.N. Assessment of Herbal Medicines by Chemometrics– Assisted Interpretation of FTIR Spectra, Journal Of Analytica Chimica Acta. 2004.
Cole C. (2001) Sunscreen protection in the ultraviolet A region: how to measure the effectiveness. Photodermatol. Photoimmunol. Photomed. 17: 2–10.
Hulshof Kf, Brussaard Jh, Kruizinga Ag, Telman J, Lowik Mr. Socio–economic status, dietary intake and 10 y trends: the Dutch National Food Consumption Survey. Eur. J. Clin. Nutr. 2003; 57: 128–37.
Juran, J.M., Planificarea calităţii, Editura Teora, 2000.
Kris–Etherton P.M., Hecker K.D., Binkoski A.E., Polyunsaturated fatty acids and cardiovascular health. Nutr Rev. 2004; 62: 414–426.
Lampi A–M. Kamal–Eldin A. Effect of a–and g– tocopherols on thermal polymerization of purified high–oleic sunflower triacylglycerols, J Amer Oil Chem Soc, 1998 75 1699–703.
Meagher EA., Barry OP., Lawson Ja., et al. Effects of vitamin E on lipid peroxidation in healthy persons. JAMA 2001; 285: 1178–1182e.
Oprean C., Kifor C. V., Suciu O. Managementul integrat al calitatii, Sibiu, Editura Universitatii “Lucian Blaga” din Sibiu, 2005.
Richardson DP., Affertsholt T., Asp NG., Bruce A., Grossklaus R., Howlett J., Pannemans D., Ross R.,Verhagen H.,Viechtbauer V. Passclai M.– Synthesis and review of existing processes. Eur J Nutr. 2003. 42(Suppl 1): 96–11.
Westenhoefer J., Bellisle F., Blundell JE., de Vries J., Edwards D., Kallus W., Milon H., Pannemans D., Tuijtelaars S., Tuorila H. Passclaim–Mental state and performance. Eur J Nutr. 2004, 43(Suppl 2): 85–117.
Yanishlieva N V and Marinova E M, Inhibited oxidation of lipids I Complex estimation of the antioxidative properties of natural and synthetic antioxidants, Fat Sci Techn, 1992 94 374–9.
Read_full_article: pdf/22-2012/22-1-2012/SU22-1-2012-Caunii.pdf
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Article Title: Total quality management of pharmaceutical preparations containing vitamin E
Authors: Angela Caunii, Lucretia Udrescu, Zoltan Szabadai , George Pribac , Monica Butnariu
Affiliation: Biochemistry, Exact Sciences Department, Banat’s University of Agricultural Faculty of Pharmacy, University of Medicine and Pharmacy “Victor Babes”, Timisoara, Romania, e–mail: angelacaunii@yahoo.com.
Faculty of Medicine, Pharmacy and Dental Medicine, “Vasile Goldis” Western University, Arad, Romania
Chemistry and Vegetal Sciences and Veterinary Medicine, Timisoara, Romania, e–mail: monicabutnariu@yahoo.com
Abstract: Due to globalization and rapid processes in technology, production’s competitiveness today is increasing. Producers must be permanently alert to find new ways to design, produce, sell and deliver their products. Today, quality is imperative. Even low–cost pharmaceutical products are expected to have a good quality. Degradation over time of many active substances with pharmaceutical interest, is a serious problem both regarding the industrial processes of obtaining, storage and use of these substances. In pharmaceutical practice there are used drugs with advanced photosensitivity; problem of their degradation over time includes the action of light as a factor capable of contributing to their entire degradation. Ultraviolet radiation is not the subject of discussion, given that during the storage and use of therapeutics drugs, they are rarely exposed to this radiation. Otherwise, the near ultraviolet radiation, with the spectral ranges 300–400nm, can be a real threat, especially in hospitals where the natural lighting is replaced by fluorescent tubes radiation. This study aims identification of physic–chemical methods used in total quality management for medicinal products containing retinal acetate (Vitamin E), conditioned as gelatine capsules (pearls).
Keywords: total quality management, gelatin capsules, Vitamin E
References: Sim, C.O. Hamdan, M.R. Ismail, Z. Ahmad, M.N. Assessment of Herbal Medicines by Chemometrics– Assisted Interpretation of FTIR Spectra, Journal Of Analytica Chimica Acta. 2004.
Cole C. (2001) Sunscreen protection in the ultraviolet A region: how to measure the effectiveness. Photodermatol. Photoimmunol. Photomed. 17: 2–10.
Hulshof Kf, Brussaard Jh, Kruizinga Ag, Telman J, Lowik Mr. Socio–economic status, dietary intake and 10 y trends: the Dutch National Food Consumption Survey. Eur. J. Clin. Nutr. 2003; 57: 128–37.
Juran, J.M., Planificarea calităţii, Editura Teora, 2000.
Kris–Etherton P.M., Hecker K.D., Binkoski A.E., Polyunsaturated fatty acids and cardiovascular health. Nutr Rev. 2004; 62: 414–426.
Lampi A–M. Kamal–Eldin A. Effect of a–and g– tocopherols on thermal polymerization of purified high–oleic sunflower triacylglycerols, J Amer Oil Chem Soc, 1998 75 1699–703.
Meagher EA., Barry OP., Lawson Ja., et al. Effects of vitamin E on lipid peroxidation in healthy persons. JAMA 2001; 285: 1178–1182e.
Oprean C., Kifor C. V., Suciu O. Managementul integrat al calitatii, Sibiu, Editura Universitatii “Lucian Blaga” din Sibiu, 2005.
Richardson DP., Affertsholt T., Asp NG., Bruce A., Grossklaus R., Howlett J., Pannemans D., Ross R.,Verhagen H.,Viechtbauer V. Passclai M.– Synthesis and review of existing processes. Eur J Nutr. 2003. 42(Suppl 1): 96–11.
Westenhoefer J., Bellisle F., Blundell JE., de Vries J., Edwards D., Kallus W., Milon H., Pannemans D., Tuijtelaars S., Tuorila H. Passclaim–Mental state and performance. Eur J Nutr. 2004, 43(Suppl 2): 85–117.
Yanishlieva N V and Marinova E M, Inhibited oxidation of lipids I Complex estimation of the antioxidative properties of natural and synthetic antioxidants, Fat Sci Techn, 1992 94 374–9.
*Correspondence: