thumb|[[Olanzapine|Zyprexa-Zydis tablets from Eli Lilly and Company, Japan]]

Zydis is a technology used to manufacture orally disintegrating tablets developed by R.P. Scherer Corporation. Zydis tablets dissolve in the mouth within 3 seconds.

History

Zydis technology was developed by R.P. Scherer Corporation (currently owned by Catalent Pharma Solutions) in 1986. The technology's first commercial application was in August, 1993, when a new dosage form of Pepcidine (famotidine) from Merck & Co. was launched in Sweden.

In November 1993 Imodium Lingual (loperamide) from Janssen Pharmaceutica was released in Germany with Zydis technology.

In December, 1996, the Food and Drug Administration approved Claritin (loratadine) RediTabs from Schering-Plough, the first prescription drug with Zydis technology sold in the U.S.

Technology

A Zydis tablet is produced by lyophilizing or freeze-drying the

drug in a matrix usually consisting of gelatin. The resulting product is very lightweight and fragile, and must be dispensed in a special blister pack.

Amipara et al., in their article "Oral disintirating<!--Yup, this is really the word that was used in the article, not "disintegrating" or anything else--> tablet of antihypertensive drug" explain the technology's limitations:

<blockquote>

The Zydis formulations consist of a drug physically trapped in a water-soluble matrix (saccharine mixture and polymer), which is freeze dried to produce a product that dissolves rapidly when placed in mouth. The ideal candidate for Zydis technology should be chemically stable and insoluble and particle size preferably less than 50 micron.

Water soluble drugs might form eutectic mixtures and not freeze adequately, so dose is limited to 60 mg and the maximum drug limit is 400 mg for water insoluble drug as large particle sizes might present sedimentation problems during manufacture.</blockquote>

Advantages and disadvantages

Advantages

Zydis tablets:

  • are convenient for the patients who have difficulty in swallowing (children, old people, bed-ridden and psychiatric patients);
  • are fast to absorb;

Disadvantages

Disadvantages include:

  • increased price due to cost-intensive production;
  • limited ability to incorporate higher concentrations of active drug.

See also

  • Orally disintegrating tablet
  • Catalent Pharma Solutions

References