Thermostable Vaccines: Past, Present and Future Perspectives Thermostable Vaccines

Vaccines stability has a major role in the success of immunization programs and saves millions of lives every year. To stabilize vaccines cold chains are developed for storage and transport, as efficiency of vaccines is hampered if they are not kept under proper temperature. Aluminum is used for making vaccine thermostable. The development of vaccine formulation is a critical part of overall development cycle of approving, testing and producing new vaccines. However, Liquid vaccine formulation is still preferred over dry formulation because of ease in using, packaging and manufacturing. Other approaches have been used to make vaccine thermostable. This study demonstrates those processes, used to develop thermo-sensitive vaccines into thermostable vaccine and also describes vaccine formulation designing and use of heat shock protein including mHSP70 and mHSP65 to generate innate and adaptive immune response.

Efficacy of Herbal Coded Test Drug Lipitame for Diabetic Dyslipidemia

Diabetes mellitus is a metabolic syndrome of carbohydrate, protein and fat metabolism resulting in hyperglycemia followed by its various early and late complications resulting in morbidity and mortality. Dyslipidemia is one of its late complications which ultimately hinder the blood flow in vascular system particularly the heart, kidneys, brain and other important organs. Dyslipidemia with both increase levels of cholesterol, triglycerides, low density lipoproteins and decrease levels of high density lipoproteins are usual findings in diabetic subjects. Keeping in mind a phase II, double-blind, randomized, case-control, comparative, multi-center study of herbal coded medicine ‘Lipitame’ and the conventional medicine ‘Atorvastatin calcium’ was conducted to find out the clinical efficacy for the management of diabetic dyslipidemia. The objectives of the clinical trial are as follows: To conduct the double blind study trial of the herbal coded medicine ‘Lipitame’ and the conventional medicine ‘Atorvastatin calcium. To evaluate the efficacy of herbal coded medicine ‘Lipitame’ for diabetic dyslipidemia. To evaluate the adverse drug reaction of the test drug ‘Lipitame’ and the controlled drug ‘Atorvastatin calcium. To analyze ‘Lipitame’ ingredients and find out its antioxidant properties by cyclic voltammetry technique. It is phase II, double-blind, randomized, case-control, prospective, comparative, multi-center trial on the subjects of age range from 30 to 70 years, both genders following inclusion and exclusion criteria having the laboratorical diagnosis of diabetes mellitus type II. Sample size for test group (Lipitame) and control group (Atorvastatin calcium) was 102 and 107 respectively that were enrolled and treated after taking written consent. Subjects (n=209) were assigned randomly to receive test drug (Lipitame) 1g capsules orally b.d and control drug (Atorvastatin calcium) 5mg capsule orally b.d for 20 weeks with monthly follow up for the evaluation of lipid profile, liver function tests, urea, creatinine, complete blood count and fasting blood sugar followed by 1 month washing period during which no medicine was given to find out the sustained effect of medicines. Comparison of data from both arms of treatment group showed significant differences in lipid profiles i.e. p<0.05 and few side effects such as dry mouth and constipations were documented in test group while diarrhea, dry mouth and muscular cramps in control group. After treatment of 5 months showed mean total cholesterol levels as 2.78±1.295 (224 mg/dl) from 3.17±1.118 (236 mg/dl) which was 5.21% reduction in test group. Similarly, the group subjected to DD1 contained the control medicine ‘atorvastatin calcium’ showed mean total cholesterol levels 3.29±1.037 (239 mg/dl) before the start of treatment at baseline and after treatment of 5 months showed mean total cholesterol levels as 2.81±1.480 (225 mg/dl) which was 6.03% reduction. After treatment of 5 months showed mean total triglyceride levels as 3.02±1.610 (201 mg/dl) from 3.48±1.069 (225 mg/dl) which was 11.26 % reduction in test group. Similarly, the group subjected to DD1 contained the control medicine ‘atorvastatin calcium’ showed mean total triglyceride levels 3.21±1.114 (211 mg/dl) before the start of treatment at baseline and after treatment of 5 months showed mean total triglyceride levels as 2.74±1.269 (188 mg/dl) which was 11.52 % reduction. After treatment of 5 months showed mean total HDL levels as 2.63±0.943 (56.3 mg/dl) from 2.25±1.105 (52.5 mg/dl) which was 6.98 % increment in test group. Similarly, the group subjected to DD1 contained the control medicine ‘atorvastatin calcium’ showed mean total HDL levels 2.62±1.061 (56.2 mg/dl) before the start of treatment at baseline and after treatment of 5 months showed mean total HDL levels as 2.94±0.712 (59.4 mg/dl) which was 5.53% increment. After treatment of 5 months showed mean total LDL levels as 3.06±1.167 (92.8 mg/dl) from 3.39±1.055 (102.7 mg/dl) which was LDL 10.12 % reduction. Similarly, the group subjected to DD1 contained the control medicine ‘atorvastatin calcium’ showed mean total LDL levels 3.12±1.070 (94.6 mg/dl) before the start of treatment at baseline and after treatment of 5 months showed mean total LDL levels as 2.77±.967 (84.1 mg/dl) which was 11.75 % reduction. It was concluded that Lipitame is also effective in contrast with Atorvastatin calcium for the treatment of diabetic dyslipidemia. There were no problematic indicators related with the consumption of test medication and thus establishing to have good acceptability by all treated patients. Beside the clinical trial, the experimental work was also done for the analysis of Lipitame’s ingredients and the exploration of their antioxidant properties. The quantitative assessment of gallic acid by HPTLC densitometry was performed and 4.886 mg/ tablet of gallic acid were reported. The antioxidant properties of the ingredients of Lipitame were studied by cyclic voltammetric technique. This antioxidant property of Lipitame’s ingredients suggest the possible hypolipidemic effects by inhibiting the oxidation of low density lipoprotein thus preventing the gathering of cholesterol in the blood vessels leading for the propagation of atherosclerotic developments. Above study shows that all five studied medicinal plants have antioxidant capacity with different capability regarding superoxide free radical scavenging aspect. Therefore, the following order obtained in their antioxidant capability. Terminalia Chebula > Phyllanthus emblica > Terminalia arjuna > Commiphora mukul (Kohistan specie) > Commiphora mukul (Tharparkar). The Terminalia chebula in comparison with other ingredients of Lipitame neutralized 50.39 % DMSO with its 20 µl extract indicating highest antioxidant property.