Zydis

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.<ref> ,

 Integrated Pharmaceutics: Applied Preformulation, Product Design, and Regulatory Science, 
  
 John Wiley & Sons, 
  
  
  
 ISBN 9781118356715,</ref>

History

Zydis technology was developed by R.P. Scherer Corporation (currently owned by Catalent Pharma Solutions) in 1986.<ref name="modified">,

 Modified-Release Drug Delivery Technology, 
  
 CRC Press, 
  
  
  
 ISBN 9780824708696,</ref> 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.<ref>

Pepcidine launch in Sweden(link). '. The Pharma Letter. 1993-08-23.

</ref>

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

Scherer announces launch of another product utilizing its Zydis technology(link). '. PR Newswire Association LLC. 1993-11-09.

</ref>

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.<ref>

Scherer Announces U.S. Marketing Clearance for the First Prescription Product Using Zydis(R) Technology(link). '. PR Newswire Association LLC. 1996-12-23.

</ref>

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. 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.<ref> Amipara. Oral disintirating tablet of antihypertensive drug(link). {{{website}}}. Journal of Drug Delivery & Therapeutics; 2013, 3(1).

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Advantages and disadvantages

Advantages

Main article: Orally disintegrating tablet § Advantages of ODTs

Zydis tablets:

• are convenient for the patients who have difficulty in swallowing (children, old people, bed-ridden and psychiatric patients);<ref name="ved">Ved Parkash,

 Fast disintegrating tablets: Opportunity in drug delivery system, 
 Journal of Advanced Pharmaceutical Technology & Research, 
 2011,
 Vol. 2(Issue: 4),
 pp. 223–35,
 DOI: 10.4103/2231-4040.90877,
 PMID: 22247889,
 PMC: 3255350,</ref><ref>Lloyd, 
  
 Ansel's Pharmaceutical Dosage Forms and Drug Delivery Systems, 
  
 Lippincott Williams & Wilkins, 
  
  
  
 ISBN 9781469871943,</ref> 

• are fast to absorb;<ref name="ved" />
• don't require water to consume;<ref name="ved" />
• have good taste (mouth feel);<ref name="ved" />
• don't provoke choking or suffocation;<ref name="ved" />
• have high microbial resistance ("due to the low moisture content in the final product, the Zydis formulation does not allow microbial growth").<ref name="hong">,

 Oral Controlled Release Formulation Design and Drug Delivery: Theory to Practice, 
  
 John Wiley & Sons, 
  
  
  
 ISBN 9781118060322,</ref>

Disadvantages

Main article: Orally disintegrating tablet § Disadvantages of ODTs

Disadvantages include:

• increased price due to cost-intensive production;<ref name="ved" />
• sensitivity to moisture (tablets can degrade at higher humidity);<ref name="hong" />
• poor physical resistance (easy to break);<ref>,

 Delivery Technologies for Biopharmaceuticals: Peptides, Proteins, Nucleic Acids and Vaccines, 
  
 John Wiley & Sons, 
  
  
  
 ISBN 9780470688403,</ref>

• limited ability to incorporate higher concentrations of active drug.<ref name="ved" />

Fast dissolving drugs with Zydis technology

Trade name	Active formula	Manufacturer	Indication
Ativan	Lorazepam	Valeant Pharmaceuticals	Anxiety disorders
Claritin RediTab	Loratadine	Schering-Plough	Allergy
Imodium	Loperamide	Johnson & Johnson	Diarrhea
Feldene melt	Piroxicam	Pfizer	Pain relief
Maxalt MLT	Rizatriptan	Merck & Co.	Headache
Motilium	Domperidone	Johnson & Johnson	Nausea and vomiting
Zelapar	Selegiline	Valeant Pharmaceuticals	Parkinson's disease, depression
Pepcid RPD	Famotidine	Johnson & Johnson	Peptic ulcer disease (PUD), gastroesophageal reflux disease (GERD/GORD)
Zyprexa	Olanzapine	Eli Lilly and Company	Schizophrenia, bipolar disorder
Zofran ODT	Ondansetron	GlaxoSmithKline	Nausea and vomiting

Data from "Fast Disintegrating Drug Delivery Systems: A Review with Special Emphasis on Fast Disintegrating Tablets" (2013).<ref> Rajendra Awasthi. Fast Disintegrating Drug Delivery Systems: A Review with Special Emphasis on Fast Disintegrating Tablets(link). '. Journal of Chemotherapy and Drug Delivery, 05/2013.

</ref>

See also

• Orally disintegrating tablet
• Catalent Pharma Solutions

External links

Zydis Fast Dissolve(link). catalent.com/. Catalent, Inc.

References

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