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Critical Parameter Encapsulation

The document discusses the key manufacturing parameters and their effects on soft gelatin capsules (softgels). The five main parameters are: 1) gel mass composition and processing, which affect rheology, strength, and permeability; 2) fill formulation and processing, which impact rheology, uniformity, weight, and stability; 3) encapsulation conditions like speed and temperature, which influence weight variation and strength; 4) drying conditions such as temperature and time, impacting moisture content, hardness, and dissolution; and 5) finishing steps like sizing and packaging, determining quality and stability. Variations in these parameters can alter the critical quality attributes and performance of softgels.

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172 views1 page

Critical Parameter Encapsulation

The document discusses the key manufacturing parameters and their effects on soft gelatin capsules (softgels). The five main parameters are: 1) gel mass composition and processing, which affect rheology, strength, and permeability; 2) fill formulation and processing, which impact rheology, uniformity, weight, and stability; 3) encapsulation conditions like speed and temperature, which influence weight variation and strength; 4) drying conditions such as temperature and time, impacting moisture content, hardness, and dissolution; and 5) finishing steps like sizing and packaging, determining quality and stability. Variations in these parameters can alter the critical quality attributes and performance of softgels.

Uploaded by

melimaulani-1
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Manufacturing Parameter Effects

components
Gel Mass Composition : gelatin type and concentration, Gel rheology, ribbon integrity and strength,
plasticizer(s) type andconcentration, moisture seam cutting and strength,softgel drying time,
content softgel hardness and brittleness, oxygen and
 Process : gel aging temperature and time volatile solute permeability, physical and
chemical stability
Fill Formulation Composition: type (hydrophilic vs.lipophilic), Fill rheology, blend and contentuniformity,
solution versus suspension,particle size, fill weight variation, seam integrity (due to
morphology(suspensions), viscosifiers, fill trapping), softgel drying time, softgel
surfactants hardness and brittleness, physical and
 Process: mixing, temperature, inert chemical stability
environment (nitrogen blanketing, yellow
lights), deaeration
Encapsulation Cooling drums and dies speed, cooling Fill weight variation, seam thickness and
drums temperature, wedge temperature, strength,production rate, drying time
ribbon thickness,softgel size
Drying Primary drying (tumble/rotary) conditions, Fill moisture content, shell moisture content,
Secondary drying (tray) conditions softgel hardness and brittleness, case
Temperature and humidity, drying rate (air hardening, shellcross-linking, dissolution
flow), drying time
Finishing Sizing, polishing, printing, inspection, Product quality, physical and chemical
packaging (container-closure) stability

JOURNAL OF PHARMACEUTICAL SCIENCES, VOL. 99, NO. 10, OCTOBER 2010

Soft Gelatin Capsules (Softgels)

RAMPURNA PRASAD GULLAPALLI

Elan Pharmaceuticals, 800 Gateway Blvd., South San Francisco, California 94080
 
Received 13 December 2009; revised 15 February 2010; accepted 19 February 2010 Published online 5 April 2010 in Wiley
Online Library (wileyonlinelibrary.com). DOI 10.1002/jps.22151

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