Coated Softgels For Pharmaceutical Drug Products

IMPROVES THERAPEUTIC PERFORMANCE AND ENHANCES PATIENTS EXPERIENCE

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Coated softgel capsules provide optimal drug release profiles, helping enhance both therapeutic performance and patients’ experiences.  Different types of coatings can be applied to help enable targeted delivery, modified release, reduced side effects, better API stability, and fixed dose combination.  

Softgel Coating Types And Applications

Enteric Coating

  • Protect API from acidic stomach environment
  • Prevent stomach irritation from the fill contents  

Delayed Release and Extended Release Coating

  • Reduce GI side effect
  • Decrease Cmax/Cmin ratio, reducing drug serum spikes

Other Applications

  • Fixed dose combinations to decrease dosing frequency
  • Moisture barrier to increase drug stability in hot and humid regions (e.g. Zone IV)  
Examples Where Coated Softgels are Desirable

Coated Softgels for Rx Drug Categories

Overcome Softgel Coating Challenges

Formulation Challenges

  • Film-forming polymer selection
    • Poor adhesion – separates from softgel
    • Poor flexibility – cracks during coating/storage
  • Plasticizer selection
    • Migration from coating to shell affects coating flexibility
    • Poor choice of plasticizer – poor film flexibility
    • High plasticizer level – stickiness, agglomeration
  • Functional properties
    • Coating level may depend on softgel shape and seal quality

Process Challenges 

  • Product temperature - High temperature can cause agglomeration 
  • Drum speed – low speeds lead to uniformity issues
  • Spray rate, pattern – high rates can cause over-wetting, sticking
Catalent Capabilities

With over 80 years of global manufacturing expertise, Catalent has the unique advantage of having an extensive network of 10 facilities on 5 continents to provide full service integrated softgel manufacturing and coating capabilities. Our Eberbach site offers integrated softgel manufacturing and coating services that help simplify supply chain management and minimize the time between encapsulation and coating. 

  • Enhance product quality and efficacy
  • Increase shelf life of the product
  • Reduce supply lead time and safety stock
Facilities

All of our sites are subject to annual review so we can remain in compliance with cGMP, FDA, EMA, and locally accreditation softgel facilities.