Self-microemulsifying drug delivery system (SMEDDS) has emerged as a vital strategy to formulate poor water soluble compounds for bioavailability enhancement. However, certain limitations are associated with SMEDDS formulations which include in vivo drug precipitation, formulation handling issues, limited lymphatic uptake, lack of predictive in vitro tests and oxidation of unsaturated fatty acids. These limitations restrict their potential usage. Inclusion of polymers or precipitation inhibitors within lipid based formulations helps to maintain drug supersaturation after dispersion. This, thereby, improves the bioavailability and reduces the variability on exposure. Also, formulating solid SMEDDS helps to overcome liquid handling and stability problems. Usage of medium chain triglycerides (MCT) and suitable antioxidants to minimize oxidation of unsaturated fatty acids are few of the steps to overcome the limitations associated with SMEDDS. The review discussed here, in detail, the limitations of SMEDDS and suitable measures that can be taken to overcome them.
Background: Cutaneous drug reactions are most frequent drug related adverse events which lead to early treatment discontinuations, high treatment cost and leading cause of morbidity and mortality. The aim of this study is to analyze the clinical patterns and offending drugs as well as their causality, severity and preventive strategies.Methods: All adverse drug reactions (ADRs) forms filled from May 2015 to April 2016 were scrutinized and forms with cutaneous drug reactions were analyzed and assessed for causality, severity and preventability.Results: Out of 300 ADR forms, 160 (53.34%) included cutaneous drug reactions. 68 (42.50%) patients were male and 92 (57.50%) were female. Maculopapular rash 58 (36.25%), fixed drug eruption (FDE) 31 (19.37), pruritus 27 (16.87%) and urticaria 19 (11.87%) were the common clinical patterns of cutaneous drug reactions. Most common offending drug classes included antibiotics, anti-inflammatory and steroidal agents. Causality assessment was done by using Naranjo’s algorithm. The result showed that out of 160 cutaneous drug reactions 141 (88.12%) ADRs were probable, 15 (9.37%) were classified as possible; 2 (1.25) doubtful and 2 (1.25%) were definitely related to the drug.Conclusions: The present study shows cutaneous drug reactions are commonly reported at ADR monitoring centre of this tertiary care hospital. Our study suggests that there is a need of intensive monitoring for ADRs in tertiary care hospital for early detection and to ensure the patient safety.
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