Zydis is a technology used to manufacture

orally disintegrating tablet An orally disintegrating tablet or orally dissolving tablet (ODT) is a drug dosage form available for a limited range of over-the-counter (OTC) and prescription medications. ODTs differ from traditional tablets in that they are designed to be ...

s developed by R.P. Scherer Corporation. Zydis tablets dissolve in the mouth within 3

second The second (symbol: s) is a unit of time derived from the division of the day first into 24 hours, then to 60 minutes, and finally to 60 seconds each (24 × 60 × 60 = 86400). The current and formal definition in the International System of U ...

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 Famotidine, sold under the brand name Pepcid among others, is a histamine H2 receptor antagonist medication that decreases stomach acid production. It is used to treat peptic ulcer disease, gastroesophageal reflux disease, and Zollinger–E ...

) from Merck & Co. was launched in

Sweden Sweden, formally the Kingdom of Sweden, is a Nordic countries, Nordic country located on the Scandinavian Peninsula in Northern Europe. It borders Norway to the west and north, and Finland to the east. At , Sweden is the largest Nordic count ...

. In November 1993 Imodium Lingual (

loperamide Loperamide, sold under the brand name Imodium, among others,Drugs.co Page accessed 4 September 2015 is a medication of the opioid receptor agonist class used to decrease the frequency of diarrhea. It is often used for this purpose in irritable ...

) from

Janssen Pharmaceutica Johnson & Johnson Innovative Medicine (formerly Janssen Pharmaceuticals) is a Belgian pharmaceutical company headquartered in Beerse, Belgium, and wholly owned by Johnson & Johnson. It was founded in 1953 by Paul Janssen. In 1961, Janssen Ph ...

was released in

Germany Germany, officially the Federal Republic of Germany, is a country in Central Europe. It lies between the Baltic Sea and the North Sea to the north and the Alps to the south. Its sixteen States of Germany, constituent states have a total popu ...

with Zydis technology. In December, 1996, the

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...

approved Claritin (

loratadine Loratadine, sold under the brand name Claritin among others, is a medication used to treat allergies. This includes allergic rhinitis (hay fever) and hives. It is also available in drug combinations such as loratadine/pseudoephedrine, in whic ...

) RediTabs from

Schering-Plough Schering-Plough Corporation was an American pharmaceutical company. It was originally the U.S. subsidiary of the German company Schering AG, which was founded in 1851 by Ernst Christian Friedrich Schering. As a result of nationalization, it becam ...

, the first prescription drug with Zydis technology sold in the U.S.

Technology

A Zydis tablet is produced by lyophilizing or

freeze-drying Freeze drying, also known as lyophilization or cryodesiccation, is a low temperature Food drying, dehydration process that involves freezing the product and lowering pressure, thereby removing the ice by Sublimation (phase transition), sublimat ...

the drug in a matrix usually consisting of

gelatin Gelatin or gelatine () is a translucent, colorless, flavorless food ingredient, commonly derived from collagen taken from animal body parts. It is brittle when dry and rubbery when moist. It may also be referred to as hydrolyzed collagen, coll ...

. 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 tablet of antihypertensive drug" explain the technology's limitations:

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 The micrometre (English in the Commonwealth of Nations, Commonwealth English as used by the International Bureau of Weights and Measures; SI symbol: μm) or micrometer (American English), also commonly known by the non-SI term micron, is a uni ...
. 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.

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; * don't require water to consume; * have good taste (mouth feel); * don't provoke choking or suffocation; * have high microbial resistance ("due to the low moisture content in the final product, the Zydis formulation does not allow microbial growth").

Disadvantages

Disadvantages include: * increased price due to cost-intensive production; * sensitivity to moisture (tablets can degrade at higher humidity); * poor physical resistance (easy to break); * limited ability to incorporate higher concentrations of active drug.

Fast dissolving drugs with Zydis technology

Data from "Fast Disintegrating Drug Delivery Systems: A Review with Special Emphasis on Fast Disintegrating Tablets" (2013).

External links

References

{{Reflist Drug delivery devices Dosage forms