photostability testing involves effect of

This may make them ineffective or form toxic photodegradation products affecting the skin. In the photoaquation reaction, the CN− group is removed with its full complement of electrons and is replaced by a water molecule without any change in the oxidation state of cobalt. Sulfides, alkenes, polyenes, and phenols (highly reactive with singlet oxygen, photochemically formed from the ground-state triplet oxygen). This could result from the inhibition of the solute diffusion into the solvent [6]. Photodehydrogenation reactions of nifedipine. PUROHIT H.O.D DRUG REGULATORY AFFAIRS POONA COLLEGE OF PHARMACY 29-12-2015 2. A. H. Santiago et al., “A, D. A. Wadke and D. E. Guttman, “Complex formation influence on reaction rate. Complex formation between photosensitive drugs and complexing agents is among the earlier methods for the stabilization of drugs. Several publications have dealt with the light sources, their spectral distribution and use [20, 40, 105–111], photostability chambers [104, 112, 113], and experimental conditions [28, 108, 114–117] for the photostability testing. These are most effective on even distribution over the surface of the drug particles in the tablet matrix [127]. It is carried out under standardized conditions to determine the extent to which the drug or the product undergoes an undesirable chemical change. The entrapment efficiency of the liposomes facilitates the enhancement of the photostability of the drugs [164, 165, 174, 178]. Double bond, C=C (oxidation/isomerization). The knowledge of the photodegradation mode and the nature of the photoproducts from the preliminary studies. In the case of the above-mentioned flavins [62, 65, 192] and fluoroquinolones [193–195], the reaction rates are a reciprocal function of the solvent viscosity. On combining the constant terms into an overall constant , the expression may be stated in the form of a first-order equation: The compliance of the analytical data to the first-order kinetics may be confirmed by the linearity of the plot of log versus with the slope equal to . However, it would depend on the reactivity of the excited state of the molecule in the particular pH range. Examples of the photostabilization of drugs by the use of an antioxidant and other agents include ascorbic acid, stabilized by α-tocopherol [181], doxorubicin HCl by sodium thiosulphate [182], mitomycin and porfiromycin [183], sulfacetamide and sulphanilamide by sulfur compounds [184], vitamin A by propyl gallate, citric acid, and BHT [185], cholecalciferol by α-tocopherol and ascorbic acid [186], cianidanol by an oxygen adsorbent [187], and riboflavin by EDTA, thiourea, DL-methionine, and sodium thiosulfate [188]. This can be achieved by the application of the principle of the spectral overlay to the pharmaceutical formulations [126]. The photostability of a drug substance may be defined as the response of the drug or drug product to the exposure to solar, UV, and visible light in the solid, semisolid, or liquid state that leads to a physical or chemical change. The use of the appropriate containers and packaging material can protect the products from the deleterious effects of light. Iqbal Ahmad, Sofia Ahmed, Zubair Anwar, Muhammad Ali Sheraz, Marek Sikorski, "Photostability and Photostabilization of Drugs and Drug Products", International Journal of Photoenergy, vol. The biological consequences of the action of light on drugs undergoing photodegradation are important. Testing is carried out on a single batch of material selected. Liposomes are microscopic and submicroscopic phospholipid vesicles with a bilayered membrane structure. The purpose of forced degradation testing studies is to evaluate the overall photosensitivity of the material for method development purposes … Solvents can exert considerable influence on the stability of the photosensitive drugs in the pharmaceutical formulations. A large number of drugs are sensitive to light [1, 2] and therefore their formulated products may degrade during manufacturing, storage, and administration. Following feedback from clients, we have recently curated a series of webinars designed for those working in the pharmaceutical, medical device and life sciences sectors with responsibility for designing and managing stability studies. Sulfacetamide (21) on UV irradiation in aqueous solutions is hydrolyzed to sulfanilamide (22) [57] [Figure 8]. W. Grimm, G. Harnischfeger, and M. Tegtmeier, S. Nema, R. J. Washkuhn, and D. R. Beussink, “Photostability testing: an overview,”, P. Halboe, “The elaboration and application of the ICH guideline on photostability: a European view,” in, T. G. Beaumont, “Photostability testing,” in, F. Sequeira and C. Vozone, “Photostability studies of drug substances and products: practical implications of the ICH guideline,”, S. R. Thatcher, R. K. Mausfield, R. B. Miller et al., “Pharmaceutical photostability a technical guide and practical interpretation of the ICH guideline and its application to pharmaceutical stability. The use of dermatological preparations or other drugs in the treatment of these disorders by application as a thin film on the skin can lead to rapid photodegradation on exposure to light. The sensitivity of a drug to a particular spectral region of light may vary with its chemical structure, photoreactivity, and nature of the dosage form. Caffeine complexation has been reported by several workers and occurs by the formation of stacking complexes [141–144]. (x)Photoinduced hydrolysis (e.g., sulfacetamide). ICH stability guidance for photostability describe the light conditions for photolytic degradation. Caffeine has been employed as a complexing agent for the photostabilization of riboflavin, a highly photosensitive drug. Reports are generated confirming light exposure over time (see image). The chain reaction is propagated by removing hydrogen atom from another molecule of the oxidant (see (26)). A. G. J. van der Houwen, J. Teeuwsen, O. Bekers, J. H. Beijnen, A. Bult, and W. J. M. Underberg, “Degradation kinetics of 7-, Y. L. Loukas, “A Plackett-Burnam screening design directs the efficient formulation of multicomponent DRV liposomes,”, Y. L. Loukas, V. Vraka, and G. Gregoriadis, “Fluorimetric studies of the formation of riboflavin-, X.-M. Wang and H.-Y. The purpose of forced degradation testing studies is to evaluate the overall photosensitivity of the material for method development purposes … These reactions may also be initiated by the interaction of a drug with endogenous substances in the body in the presence of light. Thus, an increase in the medium viscosity leads to a decrease in the reaction rate. The photostability studies are conducted with main objective that … Q1B: Stability Testing: Photostability Testing of New Drug Substances and Products. A. Ansari, and Q. N. M. Ali, “Photolysis of riboflavin in aqueous solution: a kinetic study,”, J. H. Epstein and B. U. Wintroub, “Photosensitivity due to drugs,”, L. C. Harber, I. E. Kochevar, and A. R. Shalita, “Mechanism of photosensitization to drugs in humans,” in, D. Moyal and A. Fourtanier, “Acute and chronic effects of UV on skin,” in, J. E. Roberts, “Screening dyes, drugs and dietary supplements for ocular phototoxicity,” in, H. V. DeBuys, S. B. 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Effort to standardise photostability testing of any drug is done to determine extent. Light [ 92–94 ] et al., “ a spectroelectrochemical study of the photochemical reactions may proceed free...

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