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 seconds.

History

Zydis technology was developed by R.P. Scherer Corporation (currently owned by

Catalent Pharma Solutions Catalent, Inc. (Catalent Pharma Solutions) is a multinational corporation headquartered in Somerset, New Jersey. It is a global provider of delivery technologies, development, drug manufacturing, biologics, gene therapies and consumer health p ...

) 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-Elli ...

) from Merck & Co. was launched in Sweden. In November 1993 Imodium Lingual (

loperamide Loperamide, sold under the brand name Imodium, among others,Drugs.co Page accessed September 4, 2015 is a medication used to decrease the frequency of diarrhea. It is often used for this purpose in inflammatory bowel disease and short bowel syn ...

) from

Janssen Pharmaceutica Janssen Pharmaceuticals is a pharmaceutical company headquartered in Beerse, Belgium, and wholly-owned by Johnson & Johnson. It was founded in 1953 by Paul Janssen. In 1961, Janssen Pharmaceuticals was purchased by New Jersey-based American ...

was released in

Germany Germany,, officially the Federal Republic of Germany, is a country in Central Europe. It is the second most populous country in Europe after Russia, and the most populous member state of the European Union. Germany is situated betwe ...

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 respon ...

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 combination with pseudoephedrine, a decongestant, known as lora ...

) 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 beca ...

, 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 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 ( international spelling as used by the International Bureau of Weights and Measures; SI symbol: μm) or micrometer (American spelling), also commonly known as a micron, is a unit of length in the International System of Un ...
. 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