FAQ: Orally Disintegrating Tablets or ODTs

Recognized for their patient-friendly nature, orally disintegrating tablets (ODTs) offer advantages for both patients and providers. However, their manufacturing process poses challenges that naturally give rise to questions.

Lab - LGM PharmaThis FAQ with Dr. Deepak Thassu, SVP of R&D and Regulatory Submission, answers some of the questions we often hear about ODTs. From the science of rapid disintegration to the nuances of patient-centric formulation, the insights provided here can help you navigate the intricacies of ODT development and make informed decisions.

Whether you’re adding an ODT to your pipeline for the first time or looking to deepen your ODT expertise and further develop existing products, this FAQ is your key to unlocking the potential of a unique dosage form.

 

Q: How do ODTs compare to other dosage forms like liquids, suppositories, or solids? 

A:  Four main advantages set ODTs apart from other dosage forms.

  1. Rapid disintegration: ODTs disintegrate quickly in a patient’s mouth, allowing for rapid drug release absorption.
  2. Ease of administration: ODTs are an ideal delivery method for individuals who have difficulty swallowing.
  3. Taste masking: Can be formulated to effectively mask the bitter or unpleasant taste of certain APIs.
  4. Portability: ODTs are highly portable and do not require water for administration.

Q:     Are ODTs as effective as other dosage forms? 

A:      ODTs are known to support superior patient compliance, offer increased bioavailability, and allow for faster absorption than other dosage forms. However, the overall effectiveness of ODTs compared to other dosage forms depends on multiple factors, including drug properties, therapeutic goals, and formulation quality.

Q:     Patients with swallowing difficulties have many special considerations. Can patients with swallowing difficulties still take ODT-formulated drugs if needed?

A:      ODTs are an ideal drug delivery system for patients with difficulty swallowing. They provide a safe and effective way to administer medications in pediatric, geriatric, and special needs populations.

Q:      Can ODTs be crushed or split if necessary?

A:      It’s not typically recommended, as crushing or splitting an ODT can disrupt the intended disintegration and absorption process and potentially affect the medication’s efficacy and safety. It depends on the formulation, but crushing or splitting an ODT is typically not recommended.

Q:     Do ODTs require special storage conditions?

A:      Cool, dry conditions are preferred for storing ODTs. Ideal storage conditions for ODTs offer protection from moisture, light, and extreme temperatures, hot or cold.

Q:      What influences compatibility between the API and excipients in ODT formulation?

A:      API-excipient compatibility is a crucial consideration in formulating ODTs and is influenced by multiple interconnected factors, including:

  • solubility
  • crystal morphology
  • particle size
  • hygroscopicity
  • compressibility

Q:      How does the formulation of an ODT handle moisture sensitivity?

A:      Excess free moisture in a tablet core typically causes instability in an ODT. Moisture sensitivity is a significant concern. Strategies to control free moisture include:

  • hygroscopic characteristics
  • packaging
  • excipient selection
  • formulation design

CDMO - LGM PharmaQ:     What is the bioavailability of the API in an ODT?

A:      The bioavailability of an API in an ODT is best determined case-by-case because there is a wide range of variability depending on the specific API and the formulation itself. In general, the bioavailability of an ODT is comparable to other oral dosage forms, such as conventional tablets and capsules. It’s worth noting that some ODT formulations can circumvent the first-pass effect.

Q:     What is the target shelf life of an ODT?

A:      The target shelf life of an ODT is approximately 2-3 years under ideal storage conditions. However, the target shelf life varies by specific formulation and the stability of the API. Of course, improper storage can accelerate the physical degradation of the drug substance. Proper storage is critical to maximizing the shelf life and maintaining the efficacy and safety of an ODT.

Q:     Are there any specific regulatory or quality standards that must be met for ODTs?

A:     The US Food and Drug Administration (FDA) provides guidance on the definition and quality standards for ODTs for pharmaceutical manufacturers of new and generic drug products. These recommendations are important for applicants who want to designate proposed products as ODTs. The key quality standard that must be met for a product to be labeled as an ODT is an in-vitro disintegration time of 30 seconds or less.

Q:     How will taste masking be achieved to improve patient acceptance of the ODT?

A:     Taste masking becomes a critical aspect of ODT formulation when the API has an unpleasant taste. Common taste-masking strategies include ingredients that engage a patient’s senses, polymer coatings, microencapsulation, complexation, hot-melt extrusion, and spray drying. The strategy used for taste masking in any given project depends primarily on the API and the target patient population.

Q:     Do ODTs have special storage requirements?

A:     The unique formulation properties of ODTs make them very sensitive to high temperatures and high humidity. Many ODTs have special storage requirements, and special packaging is often required to protect ODTs from moisture and humidity.

Q:     What are the best packaging options for ODTs?

A:     ODTs typically require packaging designed to protect the tablets from breakage, moisture, and other environmental factors. For most ODT products, bottles are not ideal. Standard packaging options for ODTs include:

  • Blister packs
  • Cold-formed foil packaging
  • Stick packs

Q:     What manufacturing methods are used for ODTs?

A:     Some of the most common manufacturing methods used for ODTs include:

  • direct compression
  • freeze drying (lyophilization)
  • spray drying
  • sublimation
  • molding

Are you looking to formulate and manufacture an orally disintegrating tablet? Contact us here to discuss your project.

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