Shashank Jain

ORAL DISINTEGRATING TABLETS PRESENTER : SHASHANK JAIN GUIDED BY : DR. ROHERA

Introduction ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Oral Disintegrating Tablets ,[object Object]

Fig.1. Rapid disintegration of a lyophilize Zydis tablet in minimal volume of water

Desired criteria for mouth dissolving drug delivery system ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Advantages ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Key ingredients to use ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

1.Binders ,[object Object],[object Object],[object Object],[object Object]

2.Emulsifying agents ,[object Object],[object Object],[object Object],[object Object]

3.Diluents ,[object Object],[object Object],[object Object],[object Object]

4.Disintegrants ,[object Object],[object Object],[object Object],[object Object],[object Object]

1.Effervescent Disintegrating Agents ,[object Object],[object Object],[object Object],[object Object]

2.Non Effervescent disintegrating agents ,[object Object],[object Object],[object Object],[object Object]

3.Modern Approach-Superdisintegants ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Avg. particle size and flow index for industrially used superdisintegrants . Crospovidone A2 found to be best suited .

Taste and flavour ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Various Approaches for Fast Dissolving Tablets ,[object Object],[object Object],[object Object],[object Object],[object Object]

1.Freeze drying- ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

1.1 ZYDIS (R.P. Scherer, Inc.) ,[object Object],[object Object],[object Object],FEATURES ZYDIS COMPRESSED Speed of dispersion < 3 secs >20sec Mouth Feel Smooth Gritty Dose Handling <500mg <500mg Taste Masking yes yes

Disadvantage- ,[object Object],[object Object],[object Object]

Steps involved in zydis technology Active drug + carrier/polymer Poured in wells of blister packs Trays of blister packs passed though liq N2 freezing tunnels Aluminium foil backing is applied on blisters blisters are packed

Pharmacokinetc Profile Green-Zydis 10mg, Brown-Tablet 10mg, Blue- Zydis 1.25 mg.

Other Technologies involving freeze drying- ,[object Object],[object Object],[object Object],[object Object]

2.The direct-compression ,[object Object],[object Object],[object Object],[object Object],[object Object]

2.1. FLASHTAB ,[object Object],[object Object],[object Object]

2.2. DURASOLV (Cima Labs, Inc.) ,[object Object],[object Object],[object Object],[object Object]

2.3. WOWTAB (Yamanouchi Pharma Technologies, Inc.) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

3.Spray-Drying ,[object Object],[object Object],[object Object]

4.Sublimation: ,[object Object]

Effect of volatilizing agent on porosity and crushing strength Black bars- before sublimation White bars- after sublimation

5.Mass Extrusion- ,[object Object]

Cont- ,[object Object],[object Object],[object Object]

1. Preformulation Studies- ,[object Object],[object Object],[object Object],[object Object]

Influence of excipient - Mannitol show good disintegration profile for an ODT

Influence of compaction force ,[object Object],[object Object],[object Object],[object Object]

2.Disintegration and Dissolution Studies- ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Dissolution - ,[object Object],[object Object]

Dissolution as a function of coating levels in zofran ODT

Case Study- Incorporation of “coprocessed” mannitol and microcrystalline cellulose in ODT(Glipizide) . ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

DSC PROFILE : A= Placebo, B=Mannitol , C= Coprocessed mannitol in formulation 1, D= Coprocessed mannitol in formulaiton 2.

Dissolution profile of the glipizide tablet and glipizide ODT obtained from copressing of mannitol and MCC(1:1.25)

Major limitation- ,[object Object],[object Object],[object Object],[object Object],[object Object]

How to mask bitterness ? ,[object Object],[object Object],[object Object],[object Object]

Ion Exchange Resin Example Strong acid cation exchange resin Amberlite IRP-69, Indion-224 Weak acid cation exchange resin Amberlite IRP-65, Indion-204, Indion-234 Strong base anion exchange resin Amberlite IRP-276 Weak base anion exchange resin Dimethyl amine resin

2.Forming Microgranuales Coating with taste masking material [ethylcellulose aquaous dispersion] SEED [Fine crystalline microcellulose sphere] Layering with drug

a) FMCS b) layered micro granules c) Coated micro granules

How to improve bioequivalence ? ,[object Object],[object Object]

Microencapsulation showing restricted dissolution of API

Application- Proportion of fast disintegrating systems approved according to therapeutic use. Blue –japan, Red- US, Yellow- EU

APPLICATION DRUG PRODUCTS Antidepressant Mirtazapine (SSRI) Remeron SolTab Allergy (Asthma) Fexofenadine Allegra ODT Migraine zolmitriptan Zomig Rapimelt™ Analgesic tramadol hydrochloride ULTRAM® ODT Cancer odansetron Zofran Inflammatory disease( arthritis) prednisolone Orapred

Life Cycle Managament- ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Conclusion- ,[object Object],[object Object]

Shashank Jain

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Shashank Jain