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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
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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]
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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.  ย 
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]
Process of Sublimation-
Effect of volatilizing agent on porosity and crushing strength Black bars- before sublimation White bars- after sublimation
5.Mass Extrusion- ,[object Object]
Mass extrusion instrument
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]
ย 
ย 
2.Disintegration and Dissolution Studies- ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
ย 
Dissolution - ,[object Object],[object Object]
Dissolution as a function of coating levels in zofran ODT
Case Study- Incorporation of โ€œcoprocessedโ€ 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)
ย 
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 โ€“japan, Red- US, Yellow- EU
APPLICATION DRUG PRODUCTS Antidepressant Mirtazapine (SSRI) Remeron SolTab  Allergy (Asthma) Fexofenadine Allegra ODT Migraine zolmitriptan Zomig Rapimeltโ„ข Analgesic tramadol hydrochloride ULTRAMยฎ 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]
Thank you

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Shashank Jain

  • 1. ORAL DISINTEGRATING TABLETS PRESENTER : SHASHANK JAIN GUIDED BY : DR. ROHERA
  • 2.
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  • 4. Fig.1. Rapid disintegration of a lyophilize Zydis tablet in minimal volume of water
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  • 17. Avg. particle size and flow index for industrially used superdisintegrants . Crospovidone A2 found to be best suited .
  • 18.
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  • 22.
  • 23. 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
  • 24. Pharmacokinetc Profile Green-Zydis 10mg, Brown-Tablet 10mg, Blue- Zydis 1.25 mg. ย 
  • 25.
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  • 33. Effect of volatilizing agent on porosity and crushing strength Black bars- before sublimation White bars- after sublimation
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  • 37.
  • 38. Influence of excipient - Mannitol show good disintegration profile for an ODT
  • 39.
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  • 44.
  • 45. Dissolution as a function of coating levels in zofran ODT
  • 46.
  • 47. DSC PROFILE : A= Placebo, B=Mannitol , C= Coprocessed mannitol in formulation 1, D= Coprocessed mannitol in formulaiton 2.
  • 48. Dissolution profile of the glipizide tablet and glipizide ODT obtained from copressing of mannitol and MCC(1:1.25)
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  • 50.
  • 51.
  • 52. 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
  • 53. 2.Forming Microgranuales Coating with taste masking material [ethylcellulose aquaous dispersion] SEED [Fine crystalline microcellulose sphere] Layering with drug
  • 54. a) FMCS b) layered micro granules c) Coated micro granules
  • 55.
  • 57. Application- Proportion of fast disintegrating systems approved according to therapeutic use. Blue โ€“japan, Red- US, Yellow- EU
  • 58. APPLICATION DRUG PRODUCTS Antidepressant Mirtazapine (SSRI) Remeron SolTab Allergy (Asthma) Fexofenadine Allegra ODT Migraine zolmitriptan Zomig Rapimeltโ„ข Analgesic tramadol hydrochloride ULTRAMยฎ ODT Cancer odansetron Zofran Inflammatory disease( arthritis) prednisolone Orapred
  • 59.
  • 60.