For some time now modified drug release has been studied and used extensively during the development of pharmaceutical drug products because of its advantages over immediate release formulations. As per the forecasting by Global Business Intelligence (GBI) research, the growth in oral drug delivery market will uplift in the coming years. Modified release drug products allow at least a twofold reduction in dosing when compared to a drug that is presented in a conventional immediate release form. Modified release drug products are designed to release active pharmaceutical ingredient over a longer duration of time; At least, longer than an immediate release (I.R) formulation. Many Pharmaceutical companies also utilize the proprietary advantages of Modified release formulations to extend the patent life cycle of commercial products thereby bringing in new business.
DoE is a structured, organized method for determining the relationships among factors affecting a process and its output. It has been suggested that DoE can offer returns that are four to eight times greater than the cost of running the experiments in a fraction of the time that it would take to run one-factor-at-a-time experiments. It is always important before beginning experimentation to determine the objective of an experiment, and this is no different with DoE. Identifying objectives helps focus a team on its specific aims (scientific understanding of the task/problem in hand) over a period of time. It also helps indicate what resources are and assists in managing expectations from a study's outcome. DoE studies in support of QbD are often a delicate balance between delivering defined, high-quality products and meeting predetermined time, labor, and financial constraints.
Social security systems around the world evolved at different times, at different speeds, for often very different needs. But now each country faces a universal truth: their social security organizations must be truly adaptive, ready to deliver a new type of service at a time of constant technological and social change. Each social security system is approaching this daunting task in their own way -a grand social experiment in how agencies can provide a proactive, personalized service that meets their citizens' ever-changing needs. The results are simply unknown. This article intends to start the debate on what is and is not working, and indeed on how agencies should measure their progress in moving away from the traditional transactional model. The challenges they face are immense. Populations are ageing and social security budgets are shrinking. Meanwhile, the pace of digital change is matched only by the soaring rate of customer expectations. But the opportunities are of similar scale. Advanced technology, automation and new partnerships between public-sector agencies promise a much smarter, more insight-driven service for all. Technology is only one side of this equation. As part of rethinking their entire mission, social security agencies will need new workers with new sets of skills, and for their existing workers to adapt and embrace their changing roles. None of this will be straightforward. Whatever the original purpose of the social security organization, it has now changed irrevocably. But with the right combination of talent and technology, agencies can aspire to a new model: one that is flexible enough to withstand economic and social shock and resilient enough for the challenges that lie ahead.
The main aim of proposed work was to develop vildagliptin matrix tablets (Modified release dosage form) for the treatment of the Type 2 diabetes. Modified release formulation is the drug delivery system that is designed to achieve a prolonged therapeutic effect by continuously releasing medication over an extended period of time after administration of single dose. One of the biggest drawbacks of using vildagliptin is its biological half-life of ~2 hours, so it is rapidly eliminated from the body. Owing to the shorter half-lives of vildagliptin, it is suggested that patients need to be adhered rigorously to the dosing interval and that it should be administered in two doses of 50mg per day. Since vildagliptin follows a linear pharmacokinetics across 25mg-200mg (25mg,50mg, 100mg, 200mg). Here an attempt has been made to kinetically calculate the effective dissolution profile (in vitro) for the above mentioned four strengths that will be equally effective in vivo based on the severity of the subject. Calculation part consists of Loading dose and maintenance dose calculation concept. To support the data for the in vivo behavior, comparison has been done with a patented osmotic tablet of the same.
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