Catalent Pharma Solutions is to invest more than $27 million to commercialise its next-generation oral disintegrating tablet (ODT) technology, Zydis Ultra, which allows an increased drug load and taste-masking to be incorporated into the company’s Zydis ODT dosage form, a unique freeze-dried tablet that disperses almost instantly in the mouth without water.
Zydis Ultra allows a patented and innovative drug coating to be introduced during a product’s formulation, enabling the dosage of active ingredient to be up to four times higher than for a conventional Zydis ODT, while maintaining its speed of dispersion and superior mouth feel. To date, more than 36 products have been launched using Zydis technology in more than 60 countries. The novel coating technology significantly expands the range of drug candidates that can be formulated using the Zydis ODT platform, including analgesics, anti-allergy treatments and anti-infectives.
Zydis has a number of well-established advantages over conventional oral dosage forms, including improved patient compliance, adherence and convenience, particularly within certain patient populations such as geriatrics, pediatrics and patients suffering from disorders of the central nervous system.
“Our team of scientists have been working on the next generation of ODT formulations for several years to leverage the advantages that the dose form brings to patients in terms of convenience and increased drug compliance,” said Jonathan Arnold, President, Oral Drug Delivery at Catalent. “We have been collaborating with several partners on specific products utilising the Zydis Ultra technology, and this investment coincides with these development programmes reaching proof of concept and full development stages.”
Benefits of Zydis technology include its application to a wide range of therapeutic areas, for example in treating dysphagia and for use in pediatric and geriatric applications; anti-psychotic indications, such as Parkinson’s disease and schizophrenia; anti-emetic applications (to prevent travel sickness); gastrointestinal conditions, such as diarrhoea and constipation; in anti histamines and immunotherapy applications; in the treatment of allergies; and in anxiolytic (anti-depressant) applications. Products formulated using Zydis show better pregastric absorption for certain drug compounds with more efficient delivery, as well as protection from counterfeiting, and fast onset and ease of use.
Drug products based on Zydis technology also show a high level of customer preference with enhanced market appeal due to their rapid onset of action and the ability to make products in a wide range of colours and shapes embossed with corporate logos and product codes, sold in unique packaging, including child-resistant options. The ability to make drug products that incorporate taste-masking or with flavours formulated for specific markets, including pediatrics and veterinary medicine, is another advantage.
The Zydis Ultra technology gives the same dissolution profile as Zydis ODT but with greater taste-masking capabilities and the possibility of increased doses, ie more than 400mg. Other benefits of Zydis Ultra include use with functional coatings for controlled / sustained release applications; the high speed of product manufacture; the possibility of using on-line printing, thus giving flexible solutions; a very wide range of application; and high suitability for consumer health (OTC) products, and for masking bitter or strong-tasting APIs.
Catalent also offers Zydis Bio, which is able to deliver fast-dissolve formulations of large-molecule allergens, viral vaccines, and peptides, overcoming challenges of oral delivery of proteins and peptides such as pH; peptidase and proteolytic enzyme activity; or potential interaction with other constituents of gastrointestinal fluids. The high molecular weight of peptide and protein drugs can also pose delivery problems and the sub-lingual delivery of drug through the use of Zydis Bio technology provides a solution that overcomes such challenges.
Catalent’s Zydis fast-dissolving tablet development and manufacturing operation is located within the company’s 250,000 sq ft site in Swindon, UK, which employs more than 600 people and produces more than one billion ODTs annually. Facilities and operations at the Swindon site include R&D, a pilot line with controlled and potent drug capabilities, FDA- and MCA-audited controlled drug capabilities; and, through annual reviews, compliance with FDA/cGMP regulations and operating procedures; Canadian HPB standards; UK MHRA regulations; and EU regulations.
For further information about Catalent visit www.catalent.com
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