Lamination of Pharmaceutical Tablets: Classification and Influence of Process Parameters

Area of Science:

• Pharmaceutical Manufacturing
• Materials Science
• Mechanical Engineering

Background:

• Tablet lamination is a frequent defect in pharmaceutical production.
• Lamination involves tablet failure along planes parallel to the surface.
• Existing literature lacks a clear classification of lamination types.

Purpose of the Study:

• To classify different types of tablet lamination.
• To experimentally investigate the mechanisms behind each lamination type.
• To evaluate the effectiveness of common industrial solutions for mitigating lamination.

Main Methods:

• Classification of lamination into Type 1 (air entrapment), Type 2 (shear stress), and Type 3 (tensile stress).
• Experimental study of one case for each lamination type.
• Testing three industrial solutions: slowing press speed, precompression, and tapered dies.

Main Results:

• Type 1 lamination was reduced by slowing the press or using precompression.
• Tapered dies effectively eliminated Type 2 lamination.
• No tested solution completely resolved Type 3 lamination, though tapered dies reduced its severity.

Conclusions:

• The study provides a classification and mechanistic understanding of tablet lamination types.
• Different lamination types respond variably to industrial mitigation strategies.
• Tapered dies show promise for Type 2 and reducing severity of Type 3 lamination.