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Selegiline Orally Disintegrating Tablets (Zelapar): ZYDIS TECHNOLOGY

Posted by David in February 17th 2010

Historically, target populations for new fast-dissolving or quick-disintegrating formulations have been geriatric, bedridden, developmentally disabled and pe-diatric patients. In addition, patients with limited access to water, such as travelers, and patients with persistent nausea are also suitable candidates for this practical technology. Several products already utilize Zydis technology and are presented in Table 1.

Table 1 Availability of Zydis Products

Trade Name	Active Ingredient
Generic Claritin Reditab	Loratadine drug
Feldene tablet Melt	Piroxicam canadian
Drug Maxalt-MLT	Rizatriptan 5 mg
Generic Pepcid RPD	Canadian Famotidine
Generic Zyprexa Zydis	Olanzapine medication
Canadian Zofran ODT	Ondansetron tablet
From Bogner RH,Wilkosz MF. Available at

Zydis tablets are produced by lyophilizing or freeze-drying the drug in a matrix that usually consists of gelatin. The products must be dispensed in a special blister pack, because they are lightweight and fragile. Zydis products are formulated to dissolve in two to three seconds, and they are the fastest-dissolving oral tablets worldwide. The advantages and disadvantages of Zydis technology are compared in Table 2. The three main stages involved in manufacturing and packaging of Zydis products are shown in Table 3.

Table 2 Zydis Technology: Advantages and Disadvantages

Benefits	Drawbacks
• Easy administration (no water	• Expensive manufacturing process
needed)	• Fragility of tablets
• Improvement of patient compliance	• Poor stability at higher temperatures
• Reduction in onset time	and humidity
• Ability to modify absorption
• Increase in agent’s bioavailability
• Augmentation of therapeutic efficacy
From Bogner RH, Wilkosz MF. Fast-dissolving tablets. Available at:

Table 3 Manufacturing and Packaging of Zydis Products

Stage 1	• The aqueous drug solution or suspension is prepared in bulk.
	• Precise dosing into pre-formed blisters forms the tablet shape.
Stage 2	• Filled blisters are passed through a specially designed cryogenic freezing
	process to control the ultimate size of the ice crystals. This helps to
	ensure that the tablet contains a porous matrix to facilitate rapid
	disintegration.
	• Frozen units are transferred to large-scale freeze dryers for the
	sublimation process, in which most of the remaining moisture is re-
	moved from the tablets.
Stage 3	• Open blisters are heat-sealed to ensure stability and to protect the
	product from exposure to various environmental conditions.