Zydis

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.[1]

Zyprexa-Zydis tablets from Eli Lilly and Company, Japan

History

Zydis technology was developed by R.P. Scherer Corporation (currently owned by Catalent Pharma Solutions) in 1986.[2] 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.[3]

In November 1993 Imodium Lingual (loperamide) from Janssen Pharmaceutica was released in Germany with Zydis technology.[4]

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.[5]

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.[6]

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);[7][8]
  • are fast to absorb;[7]
  • don't require water to consume;[7]
  • have good taste (mouth feel);[7]
  • don't provoke choking or suffocation;[7]
  • have high microbial resistance ("due to the low moisture content in the final product, the Zydis formulation does not allow microbial growth").[9]

Disadvantages
Main article: Orally disintegrating tablet § Disadvantages of ODTs

Disadvantages include:

  • increased price due to cost-intensive production;[7]
  • sensitivity to moisture (tablets can degrade at higher humidity);[9]
  • poor physical resistance (easy to break);[10]
  • limited ability to incorporate higher concentrations of active drug.[7]

Fast dissolving drugs with Zydis technology
Trade nameActive formulaManufacturerIndication
AtivanLorazepamValeant PharmaceuticalsAnxiety disorders
Claritin RediTabLoratadineSchering-PloughAllergy
ImodiumLoperamideJohnson & JohnsonDiarrhea
Feldene meltPiroxicamPfizerPain relief
Maxalt MLTRizatriptanMerck & Co.Headache
MotiliumDomperidoneJohnson & JohnsonNausea and vomiting
ZelaparSelegilineValeant PharmaceuticalsParkinson's disease, depression
Pepcid RPDFamotidineJohnson & JohnsonPeptic ulcer disease (PUD), gastroesophageal reflux disease (GERD/GORD)
ZyprexaOlanzapineEli Lilly and CompanySchizophrenia, bipolar disorder
Zofran ODTOndansetronGlaxoSmithKlineNausea and vomiting

Data from "Fast Disintegrating Drug Delivery Systems: A Review with Special Emphasis on Fast Disintegrating Tablets" (2013).[11]

See also
  • "Zydis Fast Dissolve". catalent.com/. Catalent, Inc. Archived from the original on 2014-08-30. Retrieved 2014-08-30.

References
  1. Al-Achi, Antoine; Gupta, Mail Ram; Stagner, William Craig (2013). "Formulation development concepts". Integrated Pharmaceutics: Applied Preformulation, Product Design, and Regulatory Science. John Wiley & Sons. p. 164. ISBN 9781118356715. Retrieved 2014-09-01.
  2. Rathbone, Michael J.; Hadgraft, Jonathan; Roberts, Michael S. (2002). "The Zydis Oral Fast-Dissolving Dosage Form". Modified-Release Drug Delivery Technology. CRC Press. p. 191. ISBN 9780824708696. Retrieved 2014-08-26.
  3. "Pepcidine launch in Sweden". The Pharma Letter. 1993-08-23. Retrieved 2014-08-30. A new formulation of Pepcidine (famotidine), utilizing R P Scherer's Zydis fast-dissolving dosage form technology, has been launched in Sweden by Merck, Sharp & Dohme, and will be rolled-out initially in other Scandinavian countries within a short time. The new formulation, known generally as Pepcidine RPD, and in Sweden as Pepcidin Rapitab, is the first H2 antagonist to dissolve in the mouth without water.
  4. "Scherer announces launch of another product utilizing its Zydis technology". PR Newswire Association LLC. 1993-11-09. Archived from the original on 2014-08-30. Retrieved 2014-08-30.
  5. "Scherer Announces U.S. Marketing Clearance for the First Prescription Product Using Zydis(R) Technology". PR Newswire Association LLC. 1996-12-23. Archived from the original on 2014-08-30. Retrieved 2014-08-30.
  6. Amipara; et al. (2013). "Oral disintirating tablet of antihypertensive drug". Journal of Drug Delivery & Therapeutics; 2013, 3(1). Archived from the original on 2014-09-03. Retrieved 2014-08-30.
  7. Ved Parkash; et al. (2011). "Fast disintegrating tablets: Opportunity in drug delivery system". Journal of Advanced Pharmaceutical Technology & Research. 2 (4): 223–35. doi:10.4103/2231-4040.90877. PMC 3255350. PMID 22247889.
  8. Allen, Lloyd (2014). "Tablets". Ansel's Pharmaceutical Dosage Forms and Drug Delivery Systems. Lippincott Williams & Wilkins. p. 267. ISBN 9781469871943. Retrieved 2014-08-30.
  9. Wen, Hong; Park, Kinam (2011). "Patented Technologies". Oral Controlled Release Formulation Design and Drug Delivery: Theory to Practice. John Wiley & Sons. p. 161. ISBN 9781118060322. Retrieved 2014-09-01.
  10. Jorgensen, Lene; Nielson, Hanne Morck (2009). "Comparison of advantages and disadvantages of different fast dissolving tablet technologies". Delivery Technologies for Biopharmaceuticals: Peptides, Proteins, Nucleic Acids and Vaccines. John Wiley & Sons. p. 399. ISBN 9780470688403. Retrieved 2014-09-01.
  11. Rajendra Awasthi; et al. (2013). "Fast Disintegrating Drug Delivery Systems: A Review with Special Emphasis on Fast Disintegrating Tablets". Journal of Chemotherapy and Drug Delivery, 05/2013. Retrieved 2014-08-30.
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