Gelatin - bovine, porcine, or piscine (fish) origin. Comes in a variety of bloom strengths, the higher the bloom strength, the more resilient the gel. Most oil based fills are encapsulated using a bloom strength of 150. When polyethylene (PEG) based fills are used, a higher bloom strength is generally used. The limitations of bovine (i.e. bovine-related diseases) and porcine (i.e. not kosher) gelatin may be overcome by piscine (fish) gelatin.

 

Plasticizer - Glycerin and Sorbitol Special are the two most common plasticizers. Glycerin is generally used with oil based fills. Sorbitol Special is used with PEG based fills. Sorbitol is not soluble in PEG and therefore will not leach out of the shell into the PEG based fill like Glycerin would. Sorbitol Special is formulated to inhibit sorbitol from crystallizing out in the gelatin shell. Do not substitute Sorbitol for Sorbitol Special.

 

Solvent - Water

 

Optional Ingredients -  Colors Flavors

 

Oils such as soybean oil and Miglyol 812 (neutral oil, triglycerides of medium chain fatty acids)

	Polyethylene Glycols: especially PEG 400 -600
	Other solvents: Any other solvent which doesn't degrade or solubilize the gelatin shell, i.e., dimethyl isosorbide, surfactants, diethylene glycol monoethly ether
	Optional Ingredients: Water or alcohol: up to 10% w/w, if needed for solubility Glycerin: 1 to 4% w/w to retard the migration of the glycerin out of the shell into the fill Polyvinylpyrrolidone: Up to 10% w/w used in combination with PEG, can increase drug solubility, and also improve stability by inhibiting drug recrystallization

 

	Suspensions can accommondate about 30% solids before viscosity and filling become a problem
	Suspensions can be heated up to 35ºC to decrease viscosity during the filling process
	Suspended solids must be smaller than 80 mesh -- mill or homogenize before filling to prevent needles from clogging during filling.
	Carriers Oily mixtures: Traditional: Soybean Oil with beeswax (4-10% w/w) and lecithin (2-4% w/w). The lecithin improves material flow, and imparts some lubrication during filling. Add enough beeswax to get a good suspension, but avoid creating a non-dispersible plug.  Gelified Oil (e.g. Geloil® SC), a ready to use system composed of soybean oil, a suspending agent, and a wetting agent. Simplifies the manufacturing process, and avoids batch to batch and supplier to supplier variability.   Polyethylene glycol PEG 800 -1000 for semi-solid fills PEG 10,000 -100,000for solid fills Or mixtures of the above. Heat up to 35ºC to make fluid enough for filling. Glycerides Glycerides of long chain fatty acids (e.g. Gelucire® 33/01). Hydrophobic with surfactant properties. Optional Ingredients: Surfactant: sorbitan derivatives such as polysorbate 80 or lecithin. For hydrophobic drugs dissolved or dispersed in an oily matrix, a surfactant of HLB 10 will increase the dispersibility of the product in aqueous fluids and also may improve bioavailability.