Why IVIVC is needed?

In a world of pharmacy, invitro quality control test is the only test available to assess quality of drug product. Now one has to recognize that testing of each batch for quality bioavailability on human is impractical, unethical, expensive and time consuming. So one has to use dissolution test to distinguish between acceptable and unacceptable drug product. So main objective of developing IVIVC is to establish the dissolution test as a surrogate for human bioequivalence studies performed during the initial approval process as well as with certain scale up and post approved changes.

Variables derived from in vivo & in vitro data employed for correlation are shown in table:

Types of MTS

MTS can be configured in multiple ways depending on the drug delivery objectives. Microstructures coated with vaccine formulation are a desirable configuration for vaccine applications, but there are other approaches that cover a variety of additional applications.

Advantages of solid-coated MTS for vaccine delivery

Pretreatment with MTS. In this configuration, the MTS is applied to the skin, creating temporary channels in the skin. A conventional patch or topical formulation is then applied over the pretreated area. The channels left behind in the skin provide less diffusional resistance than untreated skin, particularly for large, water-soluble drugs.

Therapeutic efficacy of pharmaceutical formulation is governed by factor related to both in vivo bioavailability & in vitro dissolution characteristics.

The dissolution rate of a specific dosage form is essentially an arbitrary parameter, which dependent on dissolution medium, agitation, speed etc. These all factor can modify the dissolution characteristic dramatically, so that bioavailability implication of dissolution should be proved through carefully designed IVIVC studies.

According to USP, IVIVC is a rational relationship between a biological property produced by a dosage form and a physiochemical property of same dosage form. The biological properties are Cmax, AUC etc. The physiochemical properties are % drug release under a given condition.

Microstructured transdermal systems (MTS) have been attracting increased interest in recent years. The idea of using microstructures to pierce the stratum corneum to enhance drug delivery has been around for many decades in the form of multiple-tine devices for tuberculin testing and vaccine delivery, and in the form of larger numbers of even smaller structures at least since Ganderton was issued a patent on such devices in 1974.

However, for many years, this idea failed to meet its full potential because the technology to cheaply, accurately and reproducibly manufacture the microstructures was not available. In 1998, Henry disclosed methods of making the microstructures out of silicon, based on processes utilized in the semiconductor industry.

In the journal Professor's Vigalok and Shapiro, researchers at Tel Aviv University, claim to have found a technique for replacing some chemical solvents with water.

Implementation of this method could reduce the environmental impact of the pharmaceutical manufacturing industry, which Vigalok said can use 100kg of solvents and materials to produce 1kg of medicine.

Jayant Vidhya a scientist basically from India, working in Scotland’s Dundi University found out a new technique to identify Brest cancer as early as possible.

In this technique, if body cells of breast are heated to 20oC, still the cancerous cells will remain cool from the rest of the cells.

In this program, team has operated 6 women with the breast cancer and dissects the breast with the un-cancerous cells, and repeatedly heated the cells samples to 20oC with heat pipes. Every time on heating un-cancerous cells heated up upto 20oC, but cancerous cells remains cool even on heating.

These all results are confirmed by the High resolution thermal imaging cameras.

So due to this technique, Biopsy will not have to be carried out each time to identify the breast cancer and women get freedom form the painful biopsy and quick decision can be taken up.

1. To gain attention:

If we are able to address personal questions in the initial stages of discussion then it creates very positive and amicable atmosphere. For example—

How is your son doing in his engineering course? How is your father's health?

Some cultures expect some amount of time to be spent on such questions. Real skill is to remember past personal discussions and then ask questions that are relevant to create interest of the other party.

2. Ask open questions to gather information:

The Indian government is close to rubber-stamping an $80bn industrial hub near Vishakhapatnam (Vizag) which is expected to attract pharmaceutical companies to the region.
A consortium of Mittal Energy Investments, Total SA and Petroleum Corp will be the anchor tenant at the mega oil, chemical and petrochemical hub following its $7.5bn investment.

Surrounding this will be numerous pharmaceutical and chemical manufacturing facilities, spread over the 603 sq km site.

The sheer scale of the site and the investment should ensure that it becomes a focal point for pharmaceutical activity within India. At this time it is unclear which pharmaceutical companies will be setting up in the region.

The operating in India the hub at Vizag should prove alluring to pharmaceutical companies owing to its scale plus the surrounding geography, culture and infrastructure.

PLEASE DO NOT GET PRESONAL, THESE ALL ARE SUCH FEELINGS WITH WHICH I AM LIVING FROM LAST 6-7 YEARS.

Are you a scholar? Are you a good crammer? If you are good in this practice then may be you are one of the rankers of you college/ university / board.

As we all know, that diabetes patient have to prevent himself or herself from of the food items and beverages contains artificial sweetener and sugar. Patient always has to keep themselves alert to avoid any hyperglycemic attack.

But many companies in the market now having such products, which does not have sugar. They uses aspartame or any other agents which are generally more sweeter then sugar.