of polymers for developing semi-solid gel-based pharmaceutical products.

3. Responsibilities

• Formulation Development Scientist: Conducts polymer screening and performance evaluation.
• R&D Manager: Reviews and approves polymer selection process and data.
• QA Executive: Verifies compliance of process documentation and supports audit readiness.

4. Accountability

The Head – R&D shall be accountable for the execution and maintenance of this procedure.

5. Procedure

5.1 Preparation and Planning

1. Define the objective of the gel formulation—topical, mucosal, transdermal, etc.
2. Establish performance criteria: viscosity, clarity, pH, bio-adhesiveness, spreadability, and stability.
3. Shortlist suitable polymers based on previous data, literature, or supplier recommendations.

5.2 List of Commonly Screened Polymers

• Carbomers (Carbopol 934, 940, 980)
• Hydroxypropyl methylcellulose (HPMC)
• Xanthan gum
• Poloxamer (Pluronic F127)
• Sodium alginate
• Hydroxyethyl cellulose (HEC)

5.3 Sample Preparation for Screening

1. Prepare 1% w/w gel base of each polymer in purified water.
2. Allow proper hydration for 12–24 hours depending on polymer nature.
3. Adjust pH to the target range using NaOH or TEA as required.
4. Homogenize each sample using lab-scale mixers or stirrers.

5.4 Evaluation Parameters

1. Viscosity: Measure using Brookfield viscometer at 25°C.
2. Clarity: Check visually under white and UV light.
3. Spreadability: Assess using glass slide method.
4. pH: Measure using calibrated pH meter.
5. Stability: Observe over 7 days under room and accelerated conditions.

5.5 Documentation and Ranking

1. Record each polymer’s performance in Formulation Screening Sheet (Annexure-1).
2. Assign scores to each polymer based on evaluation data.
3. Select 1–2 polymers with best overall profile for further formulation trials.

5.6 Safety and Disposal

1. Handle polymers using gloves and protective gear as per MSDS.
2. Dispose excess or unstable samples following laboratory waste disposal SOP.

6. Abbreviations

• SOP: Standard Operating Procedure
• MSDS: Material Safety Data Sheet
• R&D: Research and Development
• QA: Quality Assurance

7. Documents

1. Polymer Screening Data Sheet – Annexure-1
2. Polymer Evaluation Summary – Annexure-2
3. Formulation Planning Sheet – Annexure-3

8. References

• ICH Q8(R2): Pharmaceutical Development
• USP <795>: Pharmaceutical Compounding – Nonsterile Preparations
• Relevant MSDS of selected polymers

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Polymer Screening Data Sheet

Polymer	Viscosity	Clarity	Spreadability	Stability	Score
Carbopol 940	28000 cps	Clear	Good	Stable	9
HPMC	18000 cps	Slightly Hazy	Fair	Unstable	6

Annexure-2: Polymer Evaluation Summary

Polymer	Advantages	Limitations	Final Recommendation
Carbopol 940	High viscosity, clear gel	Requires neutralization	Recommended
Xanthan Gum	Natural origin, stable	Opaque appearance	Optional

Annexure-3: Formulation Planning Sheet

Polymer	Concentration	Preparation Date	Formulated By	Comments
Poloxamer 407	15%	01/06/2025	R&D Chemist	Thermo-sensitive gel

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2022	1.0	Initial SOP on polymer screening	New document	Head – R&D
02/06/2025	2.0	Revised evaluation criteria and annexures	Improved process control	Head – R&D