SlideShare une entreprise Scribd logo
1  sur  9
Steps In the
Development of a
Tablet
Formulation
Sandip Gite, MTech,
PhD(Pharmaceutics)
1
2
Research Areas:
• Solid Oral Dosage forms
• Sterile Dosage forms
• Oral solutions
• NDDS
• Ocular Dosage Forms
Steps In the Development of a Tablet
Formulation
3
Define Objectives
Literature Review
Preformulation Studies
Select Excipients
Formulation Design
Compatibility Studies
Analytical Method Development
Prototype Development
Evaluation of Prototypes
Scale-Up
Stability Studies
Regulatory Compliance
Clinical Trials
Scale-Up for Commercial Production (Exhibit/Reg Batches)
Post-Market Surveillance
Define Objectives
• Clearly outline the objectives of
the tablet formulation including
the desired therapeutic effect,
target patient population, and
any specific formulation
requirements.
4
5
6
7
8
9

Contenu connexe

Similaire à Steps Involved in Pharmaceutical Tablet Development

Software Used In Formulation Design Process (Pharmaceutics).Pdf
Software Used In Formulation Design Process (Pharmaceutics).PdfSoftware Used In Formulation Design Process (Pharmaceutics).Pdf
Software Used In Formulation Design Process (Pharmaceutics).PdfRAHUL PAL
 
Protocol Design & Development: What You Need to Know to Ensure a Successful S...
Protocol Design & Development: What You Need to Know to Ensure a Successful S...Protocol Design & Development: What You Need to Know to Ensure a Successful S...
Protocol Design & Development: What You Need to Know to Ensure a Successful S...Brook White, PMP
 
Considering the End before the Beginning: Choosing the Correct Endpoints - An...
Considering the End before the Beginning: Choosing the Correct Endpoints - An...Considering the End before the Beginning: Choosing the Correct Endpoints - An...
Considering the End before the Beginning: Choosing the Correct Endpoints - An...Life Sciences Network marcus evans
 
Drug Discovery Method (Bioinformatics)
Drug Discovery Method (Bioinformatics)Drug Discovery Method (Bioinformatics)
Drug Discovery Method (Bioinformatics)Hemantkrdu
 
presentation-regulators-perspective-session-2-keith-pugh_en.pdf
presentation-regulators-perspective-session-2-keith-pugh_en.pdfpresentation-regulators-perspective-session-2-keith-pugh_en.pdf
presentation-regulators-perspective-session-2-keith-pugh_en.pdfHakan Cengiz
 
FDA applications in a nutshell
FDA applications in a nutshellFDA applications in a nutshell
FDA applications in a nutshellGwenHb
 
OVERCOMING COMPLEX FORMULATION CHALLENGES FOR SMALL MOLECULES & PEPTIDES
OVERCOMING COMPLEX FORMULATION CHALLENGES FOR SMALL MOLECULES & PEPTIDESOVERCOMING COMPLEX FORMULATION CHALLENGES FOR SMALL MOLECULES & PEPTIDES
OVERCOMING COMPLEX FORMULATION CHALLENGES FOR SMALL MOLECULES & PEPTIDESiQHub
 
The Role of RWE in Drug Development_4Jun2015_final
The Role of RWE in Drug Development_4Jun2015_finalThe Role of RWE in Drug Development_4Jun2015_final
The Role of RWE in Drug Development_4Jun2015_finalBilly Franks
 
The assessed listed medicines pathway
The assessed listed medicines pathwayThe assessed listed medicines pathway
The assessed listed medicines pathwayTGA Australia
 
Multi criteria value-maximization methods for the prioritization of r&d inves...
Multi criteria value-maximization methods for the prioritization of r&d inves...Multi criteria value-maximization methods for the prioritization of r&d inves...
Multi criteria value-maximization methods for the prioritization of r&d inves...Dimitrios Gouglas
 
Application for New Drug Discovery (NDD) according to USFDA guidelines
Application for New Drug Discovery (NDD) according to USFDA guidelines Application for New Drug Discovery (NDD) according to USFDA guidelines
Application for New Drug Discovery (NDD) according to USFDA guidelines Bharathiar university
 
How and When to Kill a Program in New Product Planning
How and When to Kill a Program in New Product PlanningHow and When to Kill a Program in New Product Planning
How and When to Kill a Program in New Product PlanningAnthony Russell
 
Fundamental of-product-development
Fundamental of-product-developmentFundamental of-product-development
Fundamental of-product-developmentfarwa hussain
 
IriSys Profile Presentation widescreen V.2.3
IriSys Profile Presentation widescreen V.2.3IriSys Profile Presentation widescreen V.2.3
IriSys Profile Presentation widescreen V.2.3Chance Willkomm
 
PHARMACEUTICS.pptx
PHARMACEUTICS.pptxPHARMACEUTICS.pptx
PHARMACEUTICS.pptxPlexDon
 
regulatory requirements for drug approval ( IP-2 / UNIT -3 )
regulatory requirements for drug approval ( IP-2  / UNIT -3 )regulatory requirements for drug approval ( IP-2  / UNIT -3 )
regulatory requirements for drug approval ( IP-2 / UNIT -3 )JAYACHANDRA AKUTHOTA
 

Similaire à Steps Involved in Pharmaceutical Tablet Development (20)

Software Used In Formulation Design Process (Pharmaceutics).Pdf
Software Used In Formulation Design Process (Pharmaceutics).PdfSoftware Used In Formulation Design Process (Pharmaceutics).Pdf
Software Used In Formulation Design Process (Pharmaceutics).Pdf
 
Protocol Design & Development: What You Need to Know to Ensure a Successful S...
Protocol Design & Development: What You Need to Know to Ensure a Successful S...Protocol Design & Development: What You Need to Know to Ensure a Successful S...
Protocol Design & Development: What You Need to Know to Ensure a Successful S...
 
Considering the End before the Beginning: Choosing the Correct Endpoints - An...
Considering the End before the Beginning: Choosing the Correct Endpoints - An...Considering the End before the Beginning: Choosing the Correct Endpoints - An...
Considering the End before the Beginning: Choosing the Correct Endpoints - An...
 
Drug Discovery Method (Bioinformatics)
Drug Discovery Method (Bioinformatics)Drug Discovery Method (Bioinformatics)
Drug Discovery Method (Bioinformatics)
 
Lionberger gpha-2015
Lionberger gpha-2015Lionberger gpha-2015
Lionberger gpha-2015
 
presentation-regulators-perspective-session-2-keith-pugh_en.pdf
presentation-regulators-perspective-session-2-keith-pugh_en.pdfpresentation-regulators-perspective-session-2-keith-pugh_en.pdf
presentation-regulators-perspective-session-2-keith-pugh_en.pdf
 
FDA applications in a nutshell
FDA applications in a nutshellFDA applications in a nutshell
FDA applications in a nutshell
 
OVERCOMING COMPLEX FORMULATION CHALLENGES FOR SMALL MOLECULES & PEPTIDES
OVERCOMING COMPLEX FORMULATION CHALLENGES FOR SMALL MOLECULES & PEPTIDESOVERCOMING COMPLEX FORMULATION CHALLENGES FOR SMALL MOLECULES & PEPTIDES
OVERCOMING COMPLEX FORMULATION CHALLENGES FOR SMALL MOLECULES & PEPTIDES
 
The Role of RWE in Drug Development_4Jun2015_final
The Role of RWE in Drug Development_4Jun2015_finalThe Role of RWE in Drug Development_4Jun2015_final
The Role of RWE in Drug Development_4Jun2015_final
 
The assessed listed medicines pathway
The assessed listed medicines pathwayThe assessed listed medicines pathway
The assessed listed medicines pathway
 
Multi criteria value-maximization methods for the prioritization of r&d inves...
Multi criteria value-maximization methods for the prioritization of r&d inves...Multi criteria value-maximization methods for the prioritization of r&d inves...
Multi criteria value-maximization methods for the prioritization of r&d inves...
 
4 Dr Jian Wang Health Canada
4 Dr Jian Wang   Health Canada4 Dr Jian Wang   Health Canada
4 Dr Jian Wang Health Canada
 
Application for New Drug Discovery (NDD) according to USFDA guidelines
Application for New Drug Discovery (NDD) according to USFDA guidelines Application for New Drug Discovery (NDD) according to USFDA guidelines
Application for New Drug Discovery (NDD) according to USFDA guidelines
 
How and When to Kill a Program in New Product Planning
How and When to Kill a Program in New Product PlanningHow and When to Kill a Program in New Product Planning
How and When to Kill a Program in New Product Planning
 
Fundamental of-product-development
Fundamental of-product-developmentFundamental of-product-development
Fundamental of-product-development
 
Jennifer maguire and karen bernard
Jennifer maguire and karen bernardJennifer maguire and karen bernard
Jennifer maguire and karen bernard
 
IriSys Profile Presentation widescreen V.2.3
IriSys Profile Presentation widescreen V.2.3IriSys Profile Presentation widescreen V.2.3
IriSys Profile Presentation widescreen V.2.3
 
PHARMACEUTICS.pptx
PHARMACEUTICS.pptxPHARMACEUTICS.pptx
PHARMACEUTICS.pptx
 
Drug development team
Drug development teamDrug development team
Drug development team
 
regulatory requirements for drug approval ( IP-2 / UNIT -3 )
regulatory requirements for drug approval ( IP-2  / UNIT -3 )regulatory requirements for drug approval ( IP-2  / UNIT -3 )
regulatory requirements for drug approval ( IP-2 / UNIT -3 )
 

Dernier

CALL ON ➥9907093804 🔝 Call Girls Hadapsar ( Pune) Girls Service
CALL ON ➥9907093804 🔝 Call Girls Hadapsar ( Pune)  Girls ServiceCALL ON ➥9907093804 🔝 Call Girls Hadapsar ( Pune)  Girls Service
CALL ON ➥9907093804 🔝 Call Girls Hadapsar ( Pune) Girls ServiceMiss joya
 
Bangalore Call Girls Marathahalli 📞 9907093804 High Profile Service 100% Safe
Bangalore Call Girls Marathahalli 📞 9907093804 High Profile Service 100% SafeBangalore Call Girls Marathahalli 📞 9907093804 High Profile Service 100% Safe
Bangalore Call Girls Marathahalli 📞 9907093804 High Profile Service 100% Safenarwatsonia7
 
Bangalore Call Girls Hebbal Kempapura Number 7001035870 Meetin With Bangalor...
Bangalore Call Girls Hebbal Kempapura Number 7001035870  Meetin With Bangalor...Bangalore Call Girls Hebbal Kempapura Number 7001035870  Meetin With Bangalor...
Bangalore Call Girls Hebbal Kempapura Number 7001035870 Meetin With Bangalor...narwatsonia7
 
Bangalore Call Girls Nelamangala Number 7001035870 Meetin With Bangalore Esc...
Bangalore Call Girls Nelamangala Number 7001035870  Meetin With Bangalore Esc...Bangalore Call Girls Nelamangala Number 7001035870  Meetin With Bangalore Esc...
Bangalore Call Girls Nelamangala Number 7001035870 Meetin With Bangalore Esc...narwatsonia7
 
College Call Girls Pune Mira 9907093804 Short 1500 Night 6000 Best call girls...
College Call Girls Pune Mira 9907093804 Short 1500 Night 6000 Best call girls...College Call Girls Pune Mira 9907093804 Short 1500 Night 6000 Best call girls...
College Call Girls Pune Mira 9907093804 Short 1500 Night 6000 Best call girls...Miss joya
 
Bangalore Call Girls Majestic 📞 9907093804 High Profile Service 100% Safe
Bangalore Call Girls Majestic 📞 9907093804 High Profile Service 100% SafeBangalore Call Girls Majestic 📞 9907093804 High Profile Service 100% Safe
Bangalore Call Girls Majestic 📞 9907093804 High Profile Service 100% Safenarwatsonia7
 
CALL ON ➥9907093804 🔝 Call Girls Baramati ( Pune) Girls Service
CALL ON ➥9907093804 🔝 Call Girls Baramati ( Pune)  Girls ServiceCALL ON ➥9907093804 🔝 Call Girls Baramati ( Pune)  Girls Service
CALL ON ➥9907093804 🔝 Call Girls Baramati ( Pune) Girls ServiceMiss joya
 
VIP Call Girls Pune Vani 9907093804 Short 1500 Night 6000 Best call girls Ser...
VIP Call Girls Pune Vani 9907093804 Short 1500 Night 6000 Best call girls Ser...VIP Call Girls Pune Vani 9907093804 Short 1500 Night 6000 Best call girls Ser...
VIP Call Girls Pune Vani 9907093804 Short 1500 Night 6000 Best call girls Ser...Miss joya
 
Call Girls In Andheri East Call 9920874524 Book Hot And Sexy Girls
Call Girls In Andheri East Call 9920874524 Book Hot And Sexy GirlsCall Girls In Andheri East Call 9920874524 Book Hot And Sexy Girls
Call Girls In Andheri East Call 9920874524 Book Hot And Sexy Girlsnehamumbai
 
Aspirin presentation slides by Dr. Rewas Ali
Aspirin presentation slides by Dr. Rewas AliAspirin presentation slides by Dr. Rewas Ali
Aspirin presentation slides by Dr. Rewas AliRewAs ALI
 
VIP Call Girls Pune Sanjana 9907093804 Short 1500 Night 6000 Best call girls ...
VIP Call Girls Pune Sanjana 9907093804 Short 1500 Night 6000 Best call girls ...VIP Call Girls Pune Sanjana 9907093804 Short 1500 Night 6000 Best call girls ...
VIP Call Girls Pune Sanjana 9907093804 Short 1500 Night 6000 Best call girls ...Miss joya
 
♛VVIP Hyderabad Call Girls Chintalkunta🖕7001035870🖕Riya Kappor Top Call Girl ...
♛VVIP Hyderabad Call Girls Chintalkunta🖕7001035870🖕Riya Kappor Top Call Girl ...♛VVIP Hyderabad Call Girls Chintalkunta🖕7001035870🖕Riya Kappor Top Call Girl ...
♛VVIP Hyderabad Call Girls Chintalkunta🖕7001035870🖕Riya Kappor Top Call Girl ...astropune
 
Russian Call Girls in Pune Tanvi 9907093804 Short 1500 Night 6000 Best call g...
Russian Call Girls in Pune Tanvi 9907093804 Short 1500 Night 6000 Best call g...Russian Call Girls in Pune Tanvi 9907093804 Short 1500 Night 6000 Best call g...
Russian Call Girls in Pune Tanvi 9907093804 Short 1500 Night 6000 Best call g...Miss joya
 
Call Girls Horamavu WhatsApp Number 7001035870 Meeting With Bangalore Escorts
Call Girls Horamavu WhatsApp Number 7001035870 Meeting With Bangalore EscortsCall Girls Horamavu WhatsApp Number 7001035870 Meeting With Bangalore Escorts
Call Girls Horamavu WhatsApp Number 7001035870 Meeting With Bangalore Escortsvidya singh
 
Call Girls Service Chennai Jiya 7001305949 Independent Escort Service Chennai
Call Girls Service Chennai Jiya 7001305949 Independent Escort Service ChennaiCall Girls Service Chennai Jiya 7001305949 Independent Escort Service Chennai
Call Girls Service Chennai Jiya 7001305949 Independent Escort Service ChennaiNehru place Escorts
 
Call Girls Service Navi Mumbai Samaira 8617697112 Independent Escort Service ...
Call Girls Service Navi Mumbai Samaira 8617697112 Independent Escort Service ...Call Girls Service Navi Mumbai Samaira 8617697112 Independent Escort Service ...
Call Girls Service Navi Mumbai Samaira 8617697112 Independent Escort Service ...Call girls in Ahmedabad High profile
 
Premium Call Girls Cottonpet Whatsapp 7001035870 Independent Escort Service
Premium Call Girls Cottonpet Whatsapp 7001035870 Independent Escort ServicePremium Call Girls Cottonpet Whatsapp 7001035870 Independent Escort Service
Premium Call Girls Cottonpet Whatsapp 7001035870 Independent Escort Servicevidya singh
 

Dernier (20)

Russian Call Girls in Delhi Tanvi ➡️ 9711199012 💋📞 Independent Escort Service...
Russian Call Girls in Delhi Tanvi ➡️ 9711199012 💋📞 Independent Escort Service...Russian Call Girls in Delhi Tanvi ➡️ 9711199012 💋📞 Independent Escort Service...
Russian Call Girls in Delhi Tanvi ➡️ 9711199012 💋📞 Independent Escort Service...
 
CALL ON ➥9907093804 🔝 Call Girls Hadapsar ( Pune) Girls Service
CALL ON ➥9907093804 🔝 Call Girls Hadapsar ( Pune)  Girls ServiceCALL ON ➥9907093804 🔝 Call Girls Hadapsar ( Pune)  Girls Service
CALL ON ➥9907093804 🔝 Call Girls Hadapsar ( Pune) Girls Service
 
Bangalore Call Girls Marathahalli 📞 9907093804 High Profile Service 100% Safe
Bangalore Call Girls Marathahalli 📞 9907093804 High Profile Service 100% SafeBangalore Call Girls Marathahalli 📞 9907093804 High Profile Service 100% Safe
Bangalore Call Girls Marathahalli 📞 9907093804 High Profile Service 100% Safe
 
Bangalore Call Girls Hebbal Kempapura Number 7001035870 Meetin With Bangalor...
Bangalore Call Girls Hebbal Kempapura Number 7001035870  Meetin With Bangalor...Bangalore Call Girls Hebbal Kempapura Number 7001035870  Meetin With Bangalor...
Bangalore Call Girls Hebbal Kempapura Number 7001035870 Meetin With Bangalor...
 
Bangalore Call Girls Nelamangala Number 7001035870 Meetin With Bangalore Esc...
Bangalore Call Girls Nelamangala Number 7001035870  Meetin With Bangalore Esc...Bangalore Call Girls Nelamangala Number 7001035870  Meetin With Bangalore Esc...
Bangalore Call Girls Nelamangala Number 7001035870 Meetin With Bangalore Esc...
 
College Call Girls Pune Mira 9907093804 Short 1500 Night 6000 Best call girls...
College Call Girls Pune Mira 9907093804 Short 1500 Night 6000 Best call girls...College Call Girls Pune Mira 9907093804 Short 1500 Night 6000 Best call girls...
College Call Girls Pune Mira 9907093804 Short 1500 Night 6000 Best call girls...
 
Bangalore Call Girls Majestic 📞 9907093804 High Profile Service 100% Safe
Bangalore Call Girls Majestic 📞 9907093804 High Profile Service 100% SafeBangalore Call Girls Majestic 📞 9907093804 High Profile Service 100% Safe
Bangalore Call Girls Majestic 📞 9907093804 High Profile Service 100% Safe
 
CALL ON ➥9907093804 🔝 Call Girls Baramati ( Pune) Girls Service
CALL ON ➥9907093804 🔝 Call Girls Baramati ( Pune)  Girls ServiceCALL ON ➥9907093804 🔝 Call Girls Baramati ( Pune)  Girls Service
CALL ON ➥9907093804 🔝 Call Girls Baramati ( Pune) Girls Service
 
VIP Call Girls Pune Vani 9907093804 Short 1500 Night 6000 Best call girls Ser...
VIP Call Girls Pune Vani 9907093804 Short 1500 Night 6000 Best call girls Ser...VIP Call Girls Pune Vani 9907093804 Short 1500 Night 6000 Best call girls Ser...
VIP Call Girls Pune Vani 9907093804 Short 1500 Night 6000 Best call girls Ser...
 
Call Girls In Andheri East Call 9920874524 Book Hot And Sexy Girls
Call Girls In Andheri East Call 9920874524 Book Hot And Sexy GirlsCall Girls In Andheri East Call 9920874524 Book Hot And Sexy Girls
Call Girls In Andheri East Call 9920874524 Book Hot And Sexy Girls
 
sauth delhi call girls in Bhajanpura 🔝 9953056974 🔝 escort Service
sauth delhi call girls in Bhajanpura 🔝 9953056974 🔝 escort Servicesauth delhi call girls in Bhajanpura 🔝 9953056974 🔝 escort Service
sauth delhi call girls in Bhajanpura 🔝 9953056974 🔝 escort Service
 
Escort Service Call Girls In Sarita Vihar,, 99530°56974 Delhi NCR
Escort Service Call Girls In Sarita Vihar,, 99530°56974 Delhi NCREscort Service Call Girls In Sarita Vihar,, 99530°56974 Delhi NCR
Escort Service Call Girls In Sarita Vihar,, 99530°56974 Delhi NCR
 
Aspirin presentation slides by Dr. Rewas Ali
Aspirin presentation slides by Dr. Rewas AliAspirin presentation slides by Dr. Rewas Ali
Aspirin presentation slides by Dr. Rewas Ali
 
VIP Call Girls Pune Sanjana 9907093804 Short 1500 Night 6000 Best call girls ...
VIP Call Girls Pune Sanjana 9907093804 Short 1500 Night 6000 Best call girls ...VIP Call Girls Pune Sanjana 9907093804 Short 1500 Night 6000 Best call girls ...
VIP Call Girls Pune Sanjana 9907093804 Short 1500 Night 6000 Best call girls ...
 
♛VVIP Hyderabad Call Girls Chintalkunta🖕7001035870🖕Riya Kappor Top Call Girl ...
♛VVIP Hyderabad Call Girls Chintalkunta🖕7001035870🖕Riya Kappor Top Call Girl ...♛VVIP Hyderabad Call Girls Chintalkunta🖕7001035870🖕Riya Kappor Top Call Girl ...
♛VVIP Hyderabad Call Girls Chintalkunta🖕7001035870🖕Riya Kappor Top Call Girl ...
 
Russian Call Girls in Pune Tanvi 9907093804 Short 1500 Night 6000 Best call g...
Russian Call Girls in Pune Tanvi 9907093804 Short 1500 Night 6000 Best call g...Russian Call Girls in Pune Tanvi 9907093804 Short 1500 Night 6000 Best call g...
Russian Call Girls in Pune Tanvi 9907093804 Short 1500 Night 6000 Best call g...
 
Call Girls Horamavu WhatsApp Number 7001035870 Meeting With Bangalore Escorts
Call Girls Horamavu WhatsApp Number 7001035870 Meeting With Bangalore EscortsCall Girls Horamavu WhatsApp Number 7001035870 Meeting With Bangalore Escorts
Call Girls Horamavu WhatsApp Number 7001035870 Meeting With Bangalore Escorts
 
Call Girls Service Chennai Jiya 7001305949 Independent Escort Service Chennai
Call Girls Service Chennai Jiya 7001305949 Independent Escort Service ChennaiCall Girls Service Chennai Jiya 7001305949 Independent Escort Service Chennai
Call Girls Service Chennai Jiya 7001305949 Independent Escort Service Chennai
 
Call Girls Service Navi Mumbai Samaira 8617697112 Independent Escort Service ...
Call Girls Service Navi Mumbai Samaira 8617697112 Independent Escort Service ...Call Girls Service Navi Mumbai Samaira 8617697112 Independent Escort Service ...
Call Girls Service Navi Mumbai Samaira 8617697112 Independent Escort Service ...
 
Premium Call Girls Cottonpet Whatsapp 7001035870 Independent Escort Service
Premium Call Girls Cottonpet Whatsapp 7001035870 Independent Escort ServicePremium Call Girls Cottonpet Whatsapp 7001035870 Independent Escort Service
Premium Call Girls Cottonpet Whatsapp 7001035870 Independent Escort Service
 

Steps Involved in Pharmaceutical Tablet Development

  • 1. Steps In the Development of a Tablet Formulation Sandip Gite, MTech, PhD(Pharmaceutics) 1
  • 2. 2 Research Areas: • Solid Oral Dosage forms • Sterile Dosage forms • Oral solutions • NDDS • Ocular Dosage Forms
  • 3. Steps In the Development of a Tablet Formulation 3 Define Objectives Literature Review Preformulation Studies Select Excipients Formulation Design Compatibility Studies Analytical Method Development Prototype Development Evaluation of Prototypes Scale-Up Stability Studies Regulatory Compliance Clinical Trials Scale-Up for Commercial Production (Exhibit/Reg Batches) Post-Market Surveillance
  • 4. Define Objectives • Clearly outline the objectives of the tablet formulation including the desired therapeutic effect, target patient population, and any specific formulation requirements. 4
  • 5. 5
  • 6. 6
  • 7. 7
  • 8. 8
  • 9. 9