ABSTRACT
Most of the insulin formulations in clinical use contain phenol, meta-cresol or both as excipients. These excipients in insulin preparations provide stability and have antimicrobial properties. However, they are reported to be associated with undesirable side-effects especially localised allergic reactions. Amount of excipients injected per unit dose of insulin is a major determining factor in causation of these reactions. This review discusses the excipients in different insulin formulations available in India with potential of precipitating undesirable effects and the use of concentrated insulins to reduce these complications. To avoid the detrimental effects associated with excipients, removal of preservatives or use of insulin preparations devoid of excipients can be an option. Besides these approaches, one approach that can be considered is the use of concentrated insulin to reduce the volume of insulin dose and thereby the excipients. Concentrated insulins address the high insulin requirements of the growing population of patients with type 2 diabetes who require higher insulin doses. Concentrated insulins help in reduction of dose volume as well as amount of excipients injected per unit dose of insulin. U200 (concentrated r-DNA Human Insulin Premix 30/70-200 IU/ml) can be advantageous with better absorption from smaller quantity injected, lesser variability in absorption, lesser pain and discomfort due to smaller quantity, lesser chances of hypoglycaemia all of which can lead to better patient compliance. Thus, concentrated insulin U200 can be one of the alternatives to prevent/reduce clinical complications with excipients in insulins.
ABSTRACT
Background: Plasma cell dyscrasia (PCD) is the term used to describe the disorders characterized by neoplastic proliferation of plasma cells with the abnormal production of immunoglobulins (Ig). Patients with multiple myeloma frequently have abnormal coagulation tests. Aim of the present study were to correlate prothrombin time (PT) and Activated Partial Thromboplastin time (aPTT) with Ig concentrations in patients with newly diagnosed with PCD and to compare PT and aPTT values in untreated and treated patients diagnosed with PCDMethods: This study was conducted in the department of clinical hematology of SKIMS, a tertiary care hospital in northern India from 2015 to 2016. Patients diagnosed with PCD were advised for coagulogram (PT, aPTT) as a base line investigation. A total of 72 patients were included in the study.Results: 37% of multiple myeloma cases (newly diagnosed) and 22% of light chain disease patients presented with prolonged PT whereas none of the patients in treated cases of PCD had prolonged PT. The mean Ig concentration was significantly higher in patients with prolonged PT and aPTT compared to that of patients with normal PT and aPTT values. In IgA myeloma, the mean immunoglobulin concentration was 3643 mg/dL with a mean PT and aPTT values of 18.8s and 36.6 (p value: 0.006). The mean free light chain concentration in kappa (k) light chain myeloma was 1727 mg/L with a mean PT value of 20.5 s, mean aPTT value of 37.4 s (p-value: 0.026).Conclusions: Patients with newly diagnosed myeloma presented with prolonged PT as compared to the treated cases. Also, mean Ig concentration was significantly higher in patients with prolonged PT and aPTT compared to that of patients with normal PT and aPTT values.