Softgels are an effective delivery system for oral drugs, especially those with low solubility and/or permeability (BCS Classes II, III and IV). The softgel fill solution can contain ingredients which help increase solubility and permeability. These ingredients are mainly liquids or semisolids which are difficult to incorporate into other solid dosage forms, like tablets.
In order to improve bioavailability, some strategies focused on increasing solubility/permeability are depicted:
- Hydrophilic formulations
- Co-solvency (e.g. Nimodipine 30 mg)*
- pH related solubilization (e.g. Ibuprofen 200mg, 400 mg, 600 mg and Cetirizine 2.HCl 10mg)*
- Lipophilic formulations
- Lipid solutions (e.g. Dronabinol 2.5 mg, 5 mg, 10 mg)*
- Self emulsifying drug delivery system (e.g. Isotretinoin 10 mg, 20 mg, 30 mg, 40 mg)*
- Particle size reduction (e.g. Progesterone 100 mg, 200 mg )*
- Improve bioavailability of poorly water-soluble and poorly permeable compounds.
- Containment strategy for the manufacturing of highly potent compounds.
- Improve content uniformity of low dose compounds.
- Tamper evident.
- Counterfeiting prevention.
- Suitable for liquid and semisolid APIs.
- Easier to swallow.
- Improved patient acceptance and preference.
- Many shapes, sizes and colors for differentiation.
Softigel is an ideal partner for softgels which satisfy the following characteristics:
- Pharmaceutically acceptable for oral use.
- Sufficiently soluble to dissolve a given dose in a small volume.
- Yield a fill formulation that is stable and compatible with the shell materials.
- Prevent precipitation of the solubilized compound during manufacturing, shelf-life, and if possible, upon contact with the aqueous environment in vitro (dissolution) and in vivo (GIT). (Why is this point in bold when the others are not?)
- One- or two colors available.
- Ribbon printing.