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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

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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