Production Facilities - Soft Gelatin Capsules

We at HiGlance Laboratories pioneer the science and technology associated with the reformation of conventional oral dosage forms to soft gelatin products through our expertise in the research and development in this field. In some products, HiGlance studies show’s that the pharmacokinetic parameters (bioavailability) of our reformulated softgel products have proven the optimal drug efficacy in comparison with the other conventional solid oral dosage forms.

A Softgel or Soft Gelatin Capsule is a solid capsule (outer shell) surrounding a liquid or semi-solid center (inner fill). An active ingredient can be incorporated into the outer shell, the inner fill, or both. They are oral dosage form for medicine similar to capsules.

In soft gelatin manufacturing, warm liquid gelatin is spread over a slowly revolving, stainless steel drum. A supply of chilled dry air congeals the gelatin as the drum rotates so that a tacky, elastic band rolls off the other end. This thin band is automatically formed into capsules, filled with medicine. If the temperature and humidity are too high, gelatin will start softening and prevent solidification. From the capsulating machines the soft, moist capsules are transferred to drying drums or chambers for rapid drying depends on the size from which the moisture is to be removed. The moisture has to be removed gradually, to prevent superficial surface hardening. Drying at elevated temperature will impair dried product quality.

Processing of Soft Gel Capsules

(RH / Temp Required – 15 + 5% at 20°C)

A typical flow diagram of Soft Gel Capsules

Encapsulation –> Drying –> Packing (Blister/Strip/Alu-Alu)

In case of encapsulation & packing the required level of humidity is 30+5% at 20°C. The Drying of Soft Gel Capsule is very tricky as it has to be dried in a very controlled condition like RH / Temp, both of which should not exceed 20, along with specific air changes and time for drying. The moment any of the conditions deteriorates, the capsule may get brittle, extra soft, etc.