ODT | Orally Disintegrating Tablet | CDMO | CMO

Looking for ODT technology? Find CDMOs, CMOs offering contract manufacturing of Orally Disintegrating or Orodispersible Tablet (ODT) on PharmaCompass.

Q1. What is an orally disintegrating tablet (ODT)?

The FDA Center for Drug Evaluation and Research (CDER) defines an Orally Disintegrating Tablet (ODT) as "A solid dosage form containing medicinal substances, which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue".

Orally disintegrating tablets are also called orodispersible tablets, quick disintegrating tablets, mouth dissolving tablets, fast disintegrating tablets, fast dissolving tablets, rapid dissolving tablets, porous tablets, and rapidmelts.

Orally disintegrating tablets (ODTs) resemble a traditional tablet, but have one important difference: they disintegrate rapidly in the mouth, and therefore do not need to be swallowed. Furthermore, no liquid is required when taking the ODT medication either, which is a significant advantage when on the go.

Therefore, orodispersible tablet formulations or orally disintegrating tablet (ODT) formulations are used to facilitate oral drug delivery to geriatric and pediatric patients, as well as patients who have trouble swallowing large quantities of water.

In addition, patients suffering from oral diseases including dysphagia (swallowing disorder), motion sickness, repeated emesis as well as mental disorders prefer such orodispersible dosage forms (orodispersible tablet formulations) because they cannot swallow large quantities of water.

For ease of comparison, ODTs may be categorized into two main groups, lyophilized tablet formulations and loosely compressed tablets. Thin-film strips form a third category of solid, unit-dose, orally disintegrating products or ODT products that aim to meet the same objectives of ease of administration, patient convenience, and improved compliance.

From the perspectives of cost and simplicity, the preferred method of preparing ODTs is direct compression. However, the disintegration capacity of ODTs produced in this way is limited by the size and hardness of the resulting tablets.

The challenge, therefore, when compressing ODTs is ensuring a structure that enables fast disintegration without affecting the hardness of the tablets. Developing a dosage form with these properties requires an excipient that offers optimum cohesiveness for compaction.

Orodispersible aids or orodispersible excipients are essential for formulating orodispersible tablet formulations and may help overcome the challenges associated with the production of ODT products. Commonly used orodispersible aids include disintegrants, superdisintegrants, flavoring agents, sweetening agents, binders, fillers or diluents, lubricants, colorants, etc.

Two Excipients that make ODTs unique - Disintegrating & Superdintegrating Agents:

Disintegrants increase the available surface area of an ODT formulation (rapidly disintegrating oral dosage forms) and promote more rapid release of the drug substance.
Superdisintegrants are excipients which facilitate rapid dissolution or disintegration of ODT formulations in the oral mucosa. Effective superdisintegrants provide improved compressibility, compatibility and have no negative impact on the mechanical strength of formulations containing high-dose drugs.

Over the past three decades, orally disintegrating tablets (ODTs) have gained much attention as a preferred alternative to conventional dosage forms such as tablets and capsules. Products of ODT technologies such as ODT tablets have thus grown steadily in demand and their product pipelines are rapidly expanding.

There are many pharmaceutical manufacturers, CDMOs or CMOs (contract manufacturing organizations) offering various orally disintegrating tablet (ODT) technology for manufacturing orodispersible tablets. Some of these ODT technologies are explored in detail in the next question.

Q2. What are the different types of ODT technologies?

Technology evolution has been evident for orally disintegrating tablets (ODTs). Designed to disintegrate rapidly on contact with saliva and formulate oral drug delivery systems taken without water or chewing, these formulations offer increased convenience and ease of administration with the potential to improve compliance, particularly in certain populations where swallowing conventional dosage forms presents difficulties.

Quick dissolving drug delivery systems or fast dissolving drug delivery systems are therefore gaining popularity in the pharmaceutical industry as they enable administration of medicines without obstacles in swallowing. Consequently, quick dissolving technology or fast dissolve technology is gaining importance in the pharmaceutical contract manufacturing industry.

Some Important Types of Orodispersible Tablet (ODT) Technology or Orally Disintegrating Technology:

- Lyophilization technology or freeze-dried technology

A freeze dried oral solid dosage form or tablet is made using lyophilization technology. A suspension or solution of drug containing various excipients such as polymer, polysaccharides, preservatives, pH adjusters, flavors, sweeteners, and colors, is lyophilized and subsequently filled in blisters. Lyophilization technology is an orally disintegrating technology (quick dissolving technology), essentially involving drying at low temperatures and the removal of water via sublimation.

- Shear form technology

Shear form technology may be used for preparing orodispersible tablet formulations. The Sheaform technology involves the preparation of a floss that is known as ‘Shearform matrix’ which is produced by subjecting a feedstock containing a sugar carrier to the flash heat processing.

- Nanocrystal technology

Nanocrystal technology includes lyophilization of colloidal dispersions of drug substances and water-soluble ingredients filled into blister pockets. This method avoids manufacturing processes such as granulation, blending, and tableting, which is more advantageous for highly potent and hazardous drugs.

- Cotton candy technology

Cotton candy technology is a quick dissolving technology which utilizes a unique spinning mechanism to produce floss-like crystalline structures which mimic cotton candy. This candy floss matrix is then milled and blended with active ingredients and excipients and subsequently compressed into ODT tablets.

New drug-delivery technologies for ODT formulations are often championed by CDMOS and CMOs (contract manufacturing organizations). Pharma contract manufacturing organizations formulate alternatives to conventional dosage forms in the form of ODTs. This has led to the emergence of numerous competing versions of patented ODT technologies.

Some Important Examples of Patented ODT Technology or Orally Disintegrating Technology:

- Zydis® Fast Dissolve Technology Platform by Catalent

The Zydis® ODT (orally dissolving tablet) fast-dissolve formulation, is a unique, freeze dried oral solid dosage form that disperses almost instantly in the mouth – no water required. With more than 20 products launched in 60 countries, it continues to be the world’s best-in-class ODT technology for the production of freeze dried oral solid dosage forms.

- Orasolv Technology by Cima

This technology is being patented by CIMA Labs. It includes the use of effervescent disintegrating agents which are compressed with low pressure to produce fast dissolving tablets. The evolution of carbon dioxide from the tablet produces a fizzing sensation, which is a positive organoleptic property.

- Durasolv Technology by Cima

Durasolv Technology is a quick dissolving technology. Durasolv®is Cima’s second-generation orally disintegrating tablet formulation manufactured in a similar fashion to Orasolv®, but the tablets produced contain non-directly compressible fillers and a lubricant. The ingredients are fine particles that provide large surface area for improving dissolution rates.

- Flash Dose Technology by Fuisz

Flash dose technology has been patented by fuisz. Flash dose tablets consist of self-binding shear form matrix termed as “floss”. Furthermore, these shear form matrices are prepared by flash heat processing.

- Flashtab technology by Prographarm Laboratories

ODT tablets prepared by this technology consist of an active ingredient in the form of microcrystals. Drug microgranules may be prepared by using the conventional techniques like coacervation, microencapsulation, and extrusion- spheronization.

Q3. What are the benefits of orally disintegrating tablets (ODTs)?

Offering ease of use and convenience, orally disintegrating tablets (ODTs) and orally disintegrating powder (ODP) have become a preferred dosage form for consumers worldwide for medications in a variety of therapeutic areas.

These include traditional over-the-counter (OTC) medicines such as ibuprofen and acetaminophen, well-established prescription drugs such as montelukast and olanzapine, and a variety of other drugs for indications such as sleeplessness, erectile dysfunction, and migraine. This convenient, fast and palatable dosage form is also an excellent choice for consumers with dysphagia (swallowing disorder) as well as pediatric and geriatric patients.

Some important advantages of Oral Disintegrating Tablets (ODTs) & Orally Disintegrating Powders (ODP) for Patients and Caregivers include:

- Ease of administration to patients who cannot swallow, such as the aged, stroke victims and bedridden patients.

- Suitable for controlled/sustained release activities.

- High drug loading.

- Acceptable taste and pleasant mouth feeling.

- Increased patient compliance when traveling and for busy people, who do not have access to water readily.

- Accurate dosing as compared to liquid formulations.

- Better pregastric absorption for certain drug compounds.

- Pregastric absorption can result in improved bioavailability, reduced dose and improved clinical performance by reducing side effects.

- Excellent mouth feel properties due to the use of flavours and sweeteners which help to change the perception of “medication as bitter pill” especially in the pediatric population.

Some Important Advantages of Oral Disintegrating Tablets (ODTs) & Orally Disintegrating Powders (ODP) for Manufacturers:

- A cost-effective way to extend your drug's life cycle—formulation development and manufacturing a new ODT can create a branded, differentiated line extension.

- Gain entry into new markets and patient populations.

- Better stability than liquid dosage forms.

- Help meet the growing demand for more patient-friendly and compliant oral dosage forms.

- New business opportunities: Pharmaceutical product life-cycle management, exclusivity of product promotion and patent life extension.

Q4. What is the criteria for the drug selection of oral disintegrating tablets?

During the formulation of rapidly disintegrating oral dosage forms such as oral disintegrating tablets and other ODT products it is important for pharmaceutical manufacturers to select suitable active and inactive ingredients that impart predetermined, desired characteristics to orodispersible tablets.

Active Ingredients

The biologically active component of a drug is referred to as an active ingredient or an active substance. Active ingredient means the clinically active material that provides pharmacological activity in a pharmaceutical product, excluding formulation development components such as coatings, stabilizers, excipients or solvents, adjuvants, etc.

Active ingredients are selected to improve or impart ideal characteristics to orodispersible tablets. Some ideal characteristics for drug selection of orodispersible tablets include:

- Ability to permeate the oral mucosa.

- At least partially non-ionized at the oral cavity pH.

- Pleasant mouth feel.

- Have the ability to diffuse and partition into the epithelium of the upper GIT.

- Small to moderate molecular weight.

- Low dose drugs preferably less than 50 mg.

- Drugs should have good stability in saliva and water.

- Disintegrates without water, while leaving negligible residue in mouth.

- Short half life and frequent dosing drugs are unsuitable for ODT.

- Very bitter or unacceptable taste and odor drugs are unsuitable for ODT.

Q5. Which are the different pharmaceutical companies offering orally disintegrating tablet (ODT) technology or orodispersible tablet (ODT) technology?

There are various pharmaceutical manufacturers, CDMOs and CMOs (contract manufacturing organizations) that offer orally disintegrating tablet (ODT) technology or orodispersible tablet (ODT) technology for rapidly disintegrating oral dosage forms.

Some leading pharmaceutical manufacturers and contract manufacturing organizations for the production of orodispersible tablets are noted below:

Adare Pharmaceuticals - ADVATAB® Orally Disintegrating Tablets

Using proprietary technologies, including taste masking and orally disintegrating tablets (ODT), customized drug release, and bioavailability enhancement, Adare has demonstrated the unique ability to transform drug formulations and create novel Rx and over-the-counter (OTC) products.

- AdvaTab® Orally Disintegrating Tablets (ODTs) incorporate coated or uncoated drug particles that are uniformly dispersed in a low-moisture, rapidly disintegrating matrix. AdvaTab® technology is ideal for pediatric, geriatric, and dysphagia (swallowing disorder) patients.

Athena Drug Delivery Solutions Pvt Ltd - ODT (Oral Dispersible Tablets) Technology

Athena has been dedicated to developing lifecycle products and has developed a broad range of technology platforms for oral drug delivery with a special focus on modified release formulations as well as orodispersible dosage forms.

- Athena is a leader in developing oral dispersible products based on its platform ODT technology. The company commercially sells at least 10 pharmaceutical products, developed using its Fastmelt® platform technology, in various markets.

Catalent Pharma Solutions - ZYDIS® Fast Dissolving Tablet Technology

Whether you are considering an ODT to enhance pharmacokinetics through pre-gastric absorption, looking for a way to improve patient compliance, or seeking a marketing advantage for a valued brand, Zydis® fast dissolve technology can help enhance the value of your investment and accelerate your product’s potential.

- Catalent's Zydis® ODT fast-dissolve formulation is a unique, freeze-dried oral solid dosage form that disperses instantly in the mouth. With more than 20 pharmaceutical products launched in 60 countries, it continues to be the world’s best-in-class ODT technology.

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