requirements for stability, drug release, and quality attributes such as uniformity and appearance.

Analytical Chemists: Perform analytical tests, including drug content analysis and dissolution testing, to evaluate the drug release profile of different formulations.

Project Managers: Coordinate the formulation screening activities, ensuring that timelines are met and resources are effectively allocated.

4) Procedure

The following steps outline the procedure for screening formulations for oral delivery systems:

1. Step 1: Identification of Formulation Requirements
   1. Determine the characteristics of the drug, such as solubility, stability, and desired release profile, to guide the formulation type (e.g., tablet, capsule, oral solution, etc.).
   2. Establish the key formulation requirements, including bioavailability, tablet hardness, drug release profile, and shelf-life stability.
   3. Consider any patient-related factors such as ease of administration, dosage frequency, and potential side effects when selecting the formulation type.
2. Step 2: Selection of Excipients and Formulation Type
   1. Choose suitable excipients (e.g., fillers, binders, disintegrants, lubricants) based on the desired release mechanism and the drug’s characteristics.
   2. Consider the excipient compatibility with the drug and its ability to enhance solubility, stability, and drug release.
   3. Select the appropriate formulation type (e.g., immediate release, controlled release, or sustained release) based on the drug’s therapeutic requirements and the desired pharmacokinetic profile.
3. Step 3: Preparation of Oral Formulations
   1. Prepare the oral formulations by combining the selected excipients with the drug, ensuring uniformity and stability. Techniques such as blending, granulation, and compression may be used for solid dosage forms.
   2. If preparing solutions, ensure that the drug is fully dissolved and stable in the chosen solvent, and that the pH and viscosity of the formulation are optimized for stability and bioavailability.
   3. For tablet or capsule formulations, perform blending, granulation, drying, and compression or encapsulation to form uniform and stable dosage units.
4. Step 4: Characterization of Formulations
   1. Characterize the formulations by measuring key quality attributes such as drug content, uniformity, tablet hardness, friability, and disintegration time for solid dosage forms.
   2. For liquid formulations, measure parameters such as drug concentration, pH, viscosity, and stability under various storage conditions.
   3. Perform dissolution testing to evaluate the drug release profile under simulated gastrointestinal conditions (e.g., USP Apparatus 1 or 2). Ensure that the dissolution profile aligns with the therapeutic goals (e.g., rapid or sustained release).
5. Step 5: Stability Testing
   1. Conduct stability studies on the formulations under accelerated (e.g., 40°C, 75% humidity) and long-term conditions (e.g., 25°C, 60% humidity) to assess physical and chemical stability over time.
   2. Monitor key parameters such as drug content, appearance, dissolution, and any changes in the formulation (e.g., phase separation or discoloration) during the stability study.
6. Step 6: In Vitro Drug Release Testing
   1. Perform in vitro drug release testing under simulated gastrointestinal conditions using USP dissolution apparatus. This will help evaluate the drug’s release rate from the formulation.
   2. Compare the release profiles of different formulations to assess which formulation type offers the most suitable release rate for the therapeutic purpose.
7. Step 7: Data Collection and Analysis
   1. Record all data from the formulation preparation, characterization, and testing phases, including solubility, stability, dissolution, and drug release profiles.
   2. Analyze the data to determine which formulations meet the required specifications for stability, solubility, and release characteristics.
   3. Evaluate the formulations based on their ability to achieve the desired pharmacokinetic profile and therapeutic objectives.
8. Step 8: Documentation and Reporting
   1. Document all experimental conditions, observations, and results from the formulation screening process in a detailed report.
   2. Prepare a final report summarizing the formulation screening results, including the most promising formulations for further development based on the criteria established in Step 1.
   3. Ensure that all records are signed, dated, and stored in compliance with Good Laboratory Practices (GLP) and regulatory standards.
9. Step 9: Sample Disposal
   1. Dispose of any remaining formulation samples and testing materials following appropriate safety protocols and environmental regulations.
   2. Ensure that any hazardous materials, including excipients or solvents, are disposed of in designated chemical waste containers.

5) Documents

The following documents should be maintained during the screening of oral delivery formulations:

1. Formulation Preparation Records
2. Characterization and Testing Reports
3. Stability Testing Records
4. Dissolution Testing Reports
5. Data Analysis and Statistical Reports
6. Oral Delivery Formulation Screening Summary Report
7. Sample Disposal Records

6) Abbreviations

• API: Active Pharmaceutical Ingredient
• 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

Oral Delivery Formulation Screening Results Template

Formulation ID	Drug Content (%)	Tablet Hardness (kg)	Friability (%)	Dissolution Profile	Stability Results