Application Note

Zydis® ODT - Improved Therapeutic Profile

Source: Catalent

Zydis® fast dissolve formulation for Zelapar® (Selegiline anti-Parkinson’s compound) had a positive impact on therapeutic profile vs. Selegiline in traditional tablets:

Fig 1. zelapar zydis® fast dissolve vs. selegiline tablets

Patient Preference & Adherence To Prescriptions
Zydis® formulation demonstrates higher patient preference and adherence to prescriptions compared to traditional tablets for Selegiline in Parkinson’s disease and other therapeutic areas:

Fig 2. zydis® patient preference & adherence data

1. 12-month longitudinal patient records analysis by SDI Health, a division of IMS Health, conducted in January, 2011. Study included 1,520 US patients prescribed Zelapar, Eldepryl, or generic Selegiline.
2. Ciprandi G. Clinical utility and patient adherence with ebastine for allergic rhinitis, patient preference and adherence. Volume 4. PubMed Central, October 14, 2010.
3. Karagianis J, Grossman L, Landry J, et al. A randomized controlled trial of the effect of sublingual orally disintegrating olanzapine versus oral olanzapine on the body mass index: The PLATYPUS study. Schizophr Res. 2009;113:41-48.
4. Reig AR, Fernandez JP, Cervera JG, Navarro JH, Ferragud MA, Hortal EG. Acceptance survey of a fast dissolving tablet pharmaceutical formulation in allergic patients. satisfaction and expectancies. Allergol Immunopathol. 2006;34:107-112.

Improved Market Performance
Zelapar® (Zydis® fast dissolve formulation) launched into an already generic market, gained and retained market share at higher revenue growth rates compared to other Selegiline branded and generic compounds with the same labeled indications.

With our unmatched range of innovative technologies, formulation, production scale-up, regulatory, and commercial expertise, we can optimize your therapeutic profile.

Add Catalent modified release technologies into your product profile for better treatments. fast dissolve dose forms

Zydis® Fast Dissolve Lyophilized orally disintegrating tablets that disperse instantly (usually <3 seconds) without the need for water. Taste masking can be integrated into tablet formulation if desired.

Zydis® Ultra For increased taste masking and/or higher API loading requirements, requiring less water during manufacturing.

Zydis® Granules For the highest dose and the most taste masking options.

Zydis® Bio For allergens, peptides and viral vaccines.

Controlled release technology

OSDrC® OptiDose™ Enables the design of dividable, multi-layer, single or multi-core tablets with a practically endless variety of core numbers, shapes, sizes, and placement within the tablet. The flexible-core capability provides new alternatives in controlled release designs for drug formulators, developers, and marketers.

Extended (long-acting) Release Decreased dosing frequency compared to IR formulations. Specific amount of drug released at specific time intervals.

Delayed Release Drug released at specific targeted points in the body, based on pH or other characteristics.

Pulsed Release Short term and long term combined release (IR plus ER) in one dose form.

Optimelt™ hot melt extrusion technology

Improve bioavailability of poorly water soluble (BCS II/III/IV) compounds in a tablet form, in addition to our gold standard softgel bioavailability solutions.