Posted by admin on Mar 1, 2016 in |
The approach to the process validation of pharmaceutical manufacturing processes has been changed and the minimal approach (traditional) is no longer recommended 1-6. As the regulatory requirements are being changed, considering the patient safety and drug efficacy, an enhanced and science based approach is recommended for the process validation of medicinal product manufacturing processes. The major regulatory bodies like USFDA and EU has revised their approaches towards process validation and recommending industry to proceed with enhanced approach towards process validation. To reach the regulatory requirements regarding the process validation, tools like Quality risk management (ICH Q9), Pharmaceutical quality systems (ICH Q10) shall be useful. In-addition Quality by design is a new approach, which is a combination of several Quality system elements like Pharmaceutical development, Quality risk management, Pharmaceutical quality system which will leads to a life cycle approach to the process validation 7. This article will enable the readers to understand the science and risk approaches to the process validation, and usage of Quality by design concepts while developing...
Read More
Posted by admin on Mar 1, 2016 in |
Adverse Drug Reactions associated with drugs are common and impose a serious health related problem, which can limit the treatment options, compliance and even leads to discontinuation of therapy. Hypertension is a chronic disease condition which is considered to be one of the major cardiovascular risk factor. For the treatment of hypertension a wide range of anti-hypertensive agents are available as single or combination therapy to achieve a target blood pressure in individual patient, whereas the combination therapy increases the risk of developing Adverse Drug Reaction. Hypertensive patients often have concomitant disease condition such as hyperlipidemia, impaired glucose metabolism and renal impairment, leading to an increased rate of Cardio Vascular morbidity and mortality. Therefore, a comprehensive management of both hypertension as well as concomitant Cardio Vascular Disease risk factors is critical when treating hypertensive patients. Beta-blockers provoked psoriasis, calcium channel blockers induced gingival hyperplasia, peripheral oedema, Angiotensin Converting Enzyme inhibitors produced ankle oedema and thiazide diuretics produced hyponatremia, hyperglycemia are some of the rare and serious Adverse Drug Reaction...
Read More
Posted by admin on Mar 1, 2016 in |
Plants have been one of the important sources of medicines since the beginning of human civilization. There is a growing demand for plant based medicines, health products, pharmaceuticals, food supplements, cosmetics etc. A review of chemical constituents present in various parts of Tinospora cordifolia and their pharmacological actions is given in the present article. Tinospora cordifolia, is a commonly used shrub in Ayurvedic medicine. Although the review articles on this plant are already published, this review article is presented to comply all the updated information on its phytochemical and pharmacological activities, which were performed by widely different methods. The notable medicinal properties are anti-diabetic, anti-spasmodic, anti-malarial, anti-inflammatory, anti-arthritic, anti-oxidant, anti-allergic, anti-stress, anti-leprotic, hepatoprotective, immunmodulatory & anti-neoplastic...
Read More
Posted by admin on Mar 1, 2016 in |
The northeast region of India, considered as ‘hot spot’ of biodiversity, having unique ecological environment with hot and high-humidity conditions, has given rise to the world’s hottest chilli, ‘Bhut jolokia or Bih jolokia’, which is at least two times hotter than Red Savina Habanero in terms of Scoville heat units (SHU). The Assamese word “bhut” refers to the typical large pod size of the plant, while the term “bih” means “poison” indicating the high hotness in the fruits of the plant. It is extensively grown in North Eastern region of India, predominantly in the states of Assam, Nagaland, Manipur and Mizoram since ancient time. The main pungency principle of Bhut jolokia (Capsicum chinense Jacq.) is capsaicin (8-methyl-N-vanillyl-6-nonenamide) and its analogs collectively known as capsaicinoids synthesized in the epidermal cells of placenta of the fruit, and possesses anti-inflammatory and antioxidant activities. This review gives an update mainly on the pharmacological activities of Bhut jolokia (Capsicum Chinense Jaqc.), benefits and toxicity of...
Read More
Posted by admin on Jan 31, 2016 in |
Pulsatile drug delivery systems (PDDS) have attracted attraction because of their multiple release system. Pulsatile drug delivery systems are the new approach to overcome patient non-compliance over commercially used dosage forms. These techniques also help in treating the disorders based on circadian paradigm and the drugs are rapidly released according to the lag time decided by the carrier medium. This review covers different techniques of pulsatile drug delivery system and their marketed products. Biological rhythms play a pivot role in tolerance of any medicine given for the treatment of any disorder. This system enables the active drug for target action and inflated bioavailability with increased pharmacokinetics as well as pharmacodynamics profile of active moiety. The present review state diseases wherein pulsatile drug delivery systems are promising include asthma, peptic ulcers, cardiovascular ailments, arthritis and attention deficit syndrome in children and hypercholesterolemia. The author attracts attention of pulsatile drug delivery technique in Medical and for establishment in Pharmaceutical field...
Read More
