to assess the drug content, dissolution, and other relevant tablet properties.

Project Managers: Coordinate the tablet formulation screening activities, ensuring that testing is completed on time and that data is communicated effectively.

4) Procedure

The following steps outline the procedure for screening tablet formulations:

1. Step 1: Selection of Drug and Excipients
   1. Choose a drug candidate with desired pharmacokinetic properties, ensuring that it is suitable for tablet formulation (e.g., suitable for oral administration, stable at room temperature, etc.).
   2. Select excipients that will aid in the preparation of the tablet, such as binders, disintegrants, lubricants, fillers, and coatings. Ensure that excipients are compatible with the drug and the intended release profile.
   3. Ensure excipients selected are biocompatible, stable, and approved for use in tablet formulations.
2. Step 2: Preparation of Tablet Formulations
   1. Prepare the tablet formulations by mixing the drug with excipients, such as fillers, binders, and disintegrants, to create a uniform blend.
   2. Granulate the blend if necessary (e.g., wet granulation, dry granulation, or direct compression) to improve flow properties and ensure uniformity.
   3. Compress the granulated material into tablets using a tablet press. Control tablet weight, thickness, and hardness during the compression process.
3. Step 3: Characterization of Tablets
   1. Characterize the tablets for key quality attributes, including tablet hardness, friability, weight variation, thickness, and uniformity of drug content.
   2. Perform dissolution testing using USP apparatus 1 or 2 (basket or paddle) to evaluate the release profile of the drug from the tablet under simulated gastric or intestinal conditions.
   3. Measure the disintegration time of tablets using the appropriate disintegration apparatus to ensure they break down properly in the gastrointestinal tract.
4. Step 4: Stability Testing
   1. Perform stability testing of tablet formulations under various conditions, including accelerated stability (e.g., 40°C, 75% humidity) and long-term stability (e.g., 25°C, 60% humidity).
   2. Monitor parameters such as tablet hardness, dissolution, and drug content over time to assess formulation stability.
   3. Ensure that the tablets remain stable and maintain their quality attributes throughout the shelf life.
5. Step 5: In Vitro Release Testing
   1. Conduct in vitro release studies to evaluate the drug release profile from the tablet formulation. Use dissolution testing apparatus to simulate gastrointestinal conditions.
   2. Compare the release profile of the tablet with that of the pure drug or a reference formulation to assess the effectiveness of the formulation in controlling drug release.
6. Step 6: Data Collection and Analysis
   1. Record all data from the tablet formulation preparation, characterization, stability studies, and dissolution testing.
   2. Analyze the data to determine which formulations offer the best performance in terms of stability, drug release, and tablet quality.
   3. Use statistical methods to evaluate the significance of formulation differences and ensure reproducibility of results.
7. Step 7: Documentation and Reporting
   1. Document all findings from the tablet formulation screening process, including experimental conditions, observations, and results.
   2. Prepare a final report summarizing the results, including the recommended tablet formulation for further development based on the screening results.
   3. Ensure that all records are signed, dated, and stored in compliance with Good Laboratory Practice (GLP) standards.
8. Step 8: Sample Disposal
   1. Dispose of any remaining tablet samples and testing materials following safety protocols and environmental regulations.
   2. Ensure that hazardous materials, including solvents and chemicals, are disposed of in designated chemical waste containers.

5) Documents

The following documents should be maintained during tablet formulation screening:

1. Tablet Formulation Preparation Records
2. Characterization and Testing Reports
3. Stability Testing Records
4. In Vitro Release Testing Reports
5. Data Analysis and Statistical Reports
6. Tablet Formulation Screening Summary Report
7. Sample Disposal Records

6) Abbreviations

• API: Active Pharmaceutical Ingredient
• HPLC: High-Performance Liquid Chromatography
• USP: United States Pharmacopeia
• GLP: Good Laboratory Practices

7) References

References to regulatory guidelines and scientific literature that support this SOP:

• FDA Guidance for Pharmaceutical Development
• USP <1151> on Pharmaceutical Dosage Forms
• ICH Q8(R2) Pharmaceutical Development

8) Version

Version 1.0: Initial version of the SOP.

9) Annexure

Tablet Formulation Screening Results Template

Formulation ID	Hardness (kg)	Friability (%)	Weight Variation (mg)	Dissolution Profile	Stability Results