The document discusses fast dissolving tablets (FDTs), including their definition, significance, requirements, formulation methodologies, patented technologies, and potential drug candidates. It provides details on common FDT technologies like OraSolv and Quick-Dis and discusses effervescent agents used in formulations. The document also surveys the literature on FDT formulation and evaluation.
The document discusses fast dissolving tablets (FDTs), including their definition, significance, requirements, formulation methodologies, patented technologies, and potential drug candidates. It provides details on common FDT technologies like OraSolv and Quick-Dis and discusses effervescent agents used in formulations. The document also surveys the literature on FDT formulation and evaluation.
The document discusses fast dissolving tablets (FDTs), including their definition, significance, requirements, formulation methodologies, patented technologies, and potential drug candidates. It provides details on common FDT technologies like OraSolv and Quick-Dis and discusses effervescent agents used in formulations. The document also surveys the literature on FDT formulation and evaluation.
The document discusses fast dissolving tablets (FDTs), including their definition, significance, requirements, formulation methodologies, patented technologies, and potential drug candidates. It provides details on common FDT technologies like OraSolv and Quick-Dis and discusses effervescent agents used in formulations. The document also surveys the literature on FDT formulation and evaluation.
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Definition Significance Requirements of FDT Formulation methodologies Patented technologies Potential candidates for FDT Survey literature Definition
Fast Dissolving Tablets (FDTs) or “mouth
dissolving tablets” (MDTs) which disintegrates or dissolves rapidly without water within few seconds in the mouth. According to European pharmacopoeia, these MDTs should dissolve/disintegrate in less than three minutes.
US FDA defined ODTs as “A solid dosage form
containing medicinal substances or active ingredients which disintegrates rapidly within a few seconds when placed up on tongue” Mouth dissolving tablets are also called as Orodispersible tablets (ODTs), Fast disintegrating tablets, Orally disintegrating tablets, Quick disintegrating tablets, Fast dissolving tablets, Rapid dissolving tablets, Porous tablets, Quick melt tablets & Rapid melt tablets. significance It offer all advantages of solid dosage forms and liquid dosage forms along with special advantages, includes It provide good stability, accurate dosing, easy manufacturing, small packaging size & easy to handle. No need of water to swallow the dosage form. Easy to administer for paediatric, geriatric & institutionalized patients. More rapid drug absorption from the pre- gastric area which may produce Quick onset of action. Pre-gastric absorption of drug avoids hepatic metabolism, which reduces the dose and increase the bioavailability. The risk of chocking or suffocation during oral administration avoided. Good mouth feel property of MDDDS helps to change the basic view of medication as "bitter pill" Patient’s compliance for disabled bedridden patients and for travelling and busy people, who do not have ready access to water. Requirements of ODTs An ideal FDT should I. Dissolve / disintegrate in the mouth in matter of seconds without water. II. Have sufficient mechanical strength and good package design. III. Not affected by drug properties. IV. Effective taste masking technologies should be adopted for bitter taste drugs. V. Leave minimal or no residue in mouth after oral administration. VI. Exhibit low sensitivity to environment condition such as humidity and temperature Formulation Methodologies 1. Freeze drying or lyophilization 2. Molding 3. Cotton candy process 4. Spray drying 5. Mass extrusion 6. Nanonization 7. Three-dimensional Printing (3DP) 8. Compaction a) Melt granulation b) Phase transition process c) Sublimation 9. Conventional methods a) Dry granulation b) Wet granulation c) Direct compression OraSolv technology OraSolv technology (Cima Labs) produces tablets by low compression pressure It uses an effervescent disintegration pair that releases gas upon contact with water. Widely used effervescent disintegration pairs Acid sources Carbonate sources Citric acid, Tartaric acid, Sodium bicarbonate, Malic acid, Fumaric Sodium carbonate, acid, Adipic acid, and Potassium bicarbonate, Succinic acids. and Potassium carbonate. The carbon dioxide evolved from the reaction may provide some “fizzing” sensation, which is a positive organoleptic sensation. 20–25% of total weight of tablet effervescent agent is used. OraSolv tablets - soft and fragile nature. PakSolv - Special packaging system “Dome-shaped” blister package Prevents the vertical movement of the tablet within the depressions. Protect the tablets from breaking during transport and storage also offers light, moisture, and child resistance. Quick –Dis technology Lavipharm Laboratories Inc. (Lavipharm) invented this ideal intraoral FDDS. Thin, flexible, and quick‐dissolving film. Quick‐Dis™ provided in various packaging configurations, unit‐dose pouches to multiple‐dose blister packages.
Film with a thickness of 2 mm have disintegration
time 5 to 10 seconds & dissolving time, is around 30 seconds. Typical release profile of API is 50% released within 30 seconds and 95% within 1 minute. POTENTIAL CANDIDATES FOR FAST DISSOLVING TABLETS (FDT)
