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Vaginal Drug Delivery: The Progression of Novel Formulations

Janet Halliday at CT Scotland considers why vaginal drug delivery has been relatively excluded from new design and technological development

In the world of drug delivery, oral controlled release, novel inhaled formulations and transdermal patches have all benefited from advances in design and technology. Of lesser volume of sales are products for vaginal administration, although there have been a number of new approaches which have been developed in recent years for vaginal delivery. This article reviews the range of these products, the areas of therapy, the regulatory environment and outlines advances on the horizon.

VAGINAL PRODUCTS

Products on the market for vaginal delivery include traditional formulations, such as creams and ointments, and also less familiar formulations, such as controlled-release vaginal inserts for cervical ripening (see Figure 1) and a sponge for contraception. Some examples of vaginal products are shown in Table 1. This list is not exhaustive, but gives a cross-section of the extensive range of products available.

AREAS OF THERAPY

As shown in Table 1, the areas of therapy are as diverse as the products themselves. Creams, ointments and pessaries for local treatment of infections and direct action on the cervix are familiar products for short-term or acute indications. More unusual presentations are exemplified by the controlled release vaginal insert for the indication of cervical ripening. Rings for contraception or HRT are also less familiar presentations of commonly used drugs (see Figure 2, page 36). These can be used over a period of three weeks to three months.


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Dr Janet Halliday is Director of Research and Development at Controlled Therapeutics in East Kilbride, Scotland, a wholly-owned subsidiary of Cytokine PharmaSciences Inc, King of Prussia, Pennsylvania in the US. Janet leads development projects both in partnership with other companies and on CT projects. As well as being responsible for directing work leading to new IP, she is involved in examining both in- and out-licensing opportunities. Janet joined CT as a Bench Formulation Scientist in 1988, initially working on solid dosage forms. She transferred to work on hydrogels and was involved in scale-up and process development for the first marketed product. Janet graduated in Pharmacy from Heriot Watt University, Edinburgh and studied for her PhD at the University of Strathclyde in Glasgow, in the formulation of metered dose inhaler suspensions in conjunction with Glaxo Wellcome
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Dr Janet Halliday
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Industry Events

4th Annual Patient Recruitment and Retention in Clinical Trials

13-15 October 2008, Amsterdam

Patient recruitment is now consuming thirty percent of clinical trial time - more time than any other clinical trial activity - and almost half of all trial delays result from patient recruitment problems. As the recruiting culture becomes more sophisticated and the forces affecting patient enrollment grow more numerous and complex, pharmaceutical companies are striving to discover new strategies to facilitate enrollment in clinical trials. With increasing industry pressure to develop, test and market greater numbers of new drugs faster, pharmaceutical companies need to perform clinical trials as quickly as possible. Inefficient patient recruitment processes is a formidable barrier to pharmaceutical companies' success in launching new products. Improving the patient recruitment process is imperative to avoid wasted investments and eliminate costly delays in bringing new drugs to market -- today and even more so in the not-so-distant future. Improved patient recruitment presents one of the largest opportunities for pharmaceutical companies to eliminate delays in clinical trials, thereby making it possible to reduce time to market.  With patent time limits and large overheads meaning that any delays in the development timeline can be disastrous, a good understanding of how to successfully recruit patients for trials is vital for any company looking to succeed.
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News and Press Releases

“PACK DIFFERENT” with EMBALLAGE 2008

“Business, Innovation, Outlook” are the watchwords for the 38th World Packaging Exhibition which opens in Paris from 17 to 21 November 2008. Fifteen months before the key packaging event of the end of 2008, EMBALLAGE displays its differences to offer you a new edition that is even more representative, international and rich in new features.
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