Orally disintegrating tablets (ODTs) is fast-dissolve formulation. The unique, freeze-dried oral solid dosage form disperses almost instantly in the mouth – no water required when it is taking. It has better patient acceptance and compliance, especially for patients often find swallowing a challenge.
The principal ODTs manufacturing processes include compressed tableting process, freeze-dried tableting technology, freeze-dried ODTs have gained much attention as a preferred alternative with much faster disintegrating compared to compressed tableting dosage forms.
There are many freeze-dried ODTs launched in the market including Desloratadine, Olanzapine, medical beauty and skincare, etc. Freeze-dried ODTs offer improved biopharmaceutical properties, improved efficacy and better safety compared with conventional oral dosage forms. The freeze-dried ODT drugs can be designed to treat acute conditions with the benefit of rapid onset of action. Furthermore, if the drug is absorbed within the oral cavity rather than being digested, it avoids the first pass of the liver. This pre-gastric absorption can reduce side effects caused by metabolites formed by liver enzymes. Freeze-dried ODTs have better patient acceptance and compliance, which can help to enhance the value of your investment and accelerate your product’s potential.
The main advantages of freeze-dried ODTs:
Rapid disintegration: The formed matrix structure of freeze-dried ODT is very porous in nature and rapidly dissolve or disintegrate upon contact with saliva
Rapid onset of action: Disintegration in the oral cavity, oral mucosa absorption; reduces the liver first pass effect
High drug loading: Ingredients are main drugs and excipients, less additives
Stability: Vacuum freeze-drying formulation with limited water content, no preservatives and easy to store
A wide range of applications:
Dysphagia
Pediatric and geriatric application
Fast Onset
Ease of use
A wide range of therapeutic areas
Anti-psychotic (Parkinson’s disease, schizophrenia)
Anti-emetic (Travel sickness)
Gastro (Diarrhea, Constipation)
Allergy (Anti histamine, immunotherapy)
Anxiolytic (Anti-depressants)
Vaccine
Tofflon solutions for the Freeze-dried ODTs
Tofflon Freeze-dried ODTs System has five main steps to process freeze -dried ODTs
Step 1 – Preparation
The bulk API, excipient and other auxiliary materials are formulated into a liquid solution or suspension.
Step 2 – Filling and rapid freezing
The liquid or suspension is precisely filled into pre-formed blisters and passes through a specially designed cryogenic freezing process to control the ultimate size of the ice crystals.
Stage 3 – Lyophilization
The frozen units are then transferred to large-scale freeze dryers for the lyophilization process. Because of contact area between the shelves and tablets is large and thin thickness of tablets, the lyophilization cycle is shortened greatly.
Stage 4 –Inspection & Sealing
The blisters containing the dried tablets are inspected 100%, then transferred to be sealed via a heat-seal process to protect the product from varying environmental conditions and ensure long-term stability.
Step 5-Packaging
The blisters are packed in cartons ready for delivery to the patient.
Summary
Freeze-dried ODTs have distinctive technical advantages over traditional compressed tableting dosage forms. Therefore it brings a wide range of applications and therapeutic areas. It is a promising niche markets for pharmaceutical and cosmetic applications.
Tofflon Freeze-dried ODTs System and relevant technical process support offer competitive and well-proven integrated Freeze-dried ODTs solutions which will support you to successfully develop your new products into new business area and reduce your products launch time to market.