Soft gelatine capsules

Dronabinol. Marinol ( ii7R-/n7 j )-6i7,7,8,I0i7-tetrahydro-6,6,9-trimethyl-3-pentyl-6JT-diben2o(B,D) pyran-I-ol is the principal psychoactive substance present in Cannabis sativa F., ie, marijuana. It is a controlled substance, formulated in sesame oil and encapsulated in soft gelatin capsules for oral adrninistration. 

Fig. 2. Rotary die process of soft gelatin capsules where A represents the drug mix B, the mold wedge C, gelatin ribbons D, die roUs E, capsules and F,...

This pigment is recognized by the U.S. Food and Drug Administration (21 Code of Federal Regulations, Part 73) as a color additive exempted from certification (Subpart A, Foods, Section 73.35, Astaxanthin). Formulations containing astaxanthin include soft gelatin capsules containing 100 mg equivalents of total carotenoids, a skin care... 

Although the patent holders at first sold both filled and empty soft gelatin capsules, the sale of empty shells was discontinued after 1837 [2]. However, the demand that had been created for the empty capsules... 

Soft gelatin capsules are available in a wide variety of sizes and shapes. Specialty packages in tube form (ophthalmics, ointments) or bead form (various cosmetics) are possible [3],... 

One disadvantage of soft gelatin capsules is that such products often must be contracted out to a limited number of firms having the necessary filling equipment and expertise. Materials must be shipped to the soft gelatin capsule facility, and products must be shipped back to the pharmaceutical manufacturer for final packaging and distribution. Additional quality control measures may be required. 

Soft gelatin capsules are not an inexpensive dosage form, particularly when compared to direct compression tablets [3]. There is a more intimate contact between the shell and its liquid contents than exists with dry-filled hard gelatin capsules, which increases the possibility of interactions. For instance, chloral hydrate formulated with an oily vehicle exerts a proteolytic effect on the gelatin shell however, the effect is greatly reduced when the oily vehicle is replaced with polyethylene glycol [3]. 

The formulation for soft gelatin capsules involves liquid rather than powder technology. Materials are generally formulated to produce the smallest possible capsule consistent with maximum stability, therapeutic effectiveness, and manufacture efficiency [3],... 

JP Stanley. Capsules II. Soft gelatin capsules. In L Lachman, H A Lieberman, J L Kanig, eds. The Theory and Practice of Industrial Pharmacy, 2nd ed, Philadelphia Lea and Febiger, 1976, pp 404-420. 

IR Berry. Improving bioavailability with soft gelatin capsules. DrugCosIndl33(3) 32,33,102,105-108,1983. 

IR Berry. One-piece, soft gelatin capsules for pharmaceutical products. Pharm Eng 5(5) 15—19, 1985. 

LJ Fuccella, G Bolcioni, V Tamassia, L Ferario, G Tognoni. Human pharmacokinetics and bioavailability of temazepam administered in soft gelatin capsules. Eur J Clin Pharmacol 12 383-386, 1977. 

FS Horn, SA Veresh, WR Ebert. Soft gelatin capsules II. Oxygen permeability study of capsule shells. J Pharm Sci 64 851-857, 1975. 

NA Armstrong, KC James, WKL Pugh. Drug migration into soft gelatin capsule shells and its effect on the in-vitro availability. J Pharm Pharmacol 36 361— 365, 1984. 

B. Tablets, Hard Gelatin Capsules, Soft Gelatin Capsules, and Granules... 

Calcitriol must be protected from air and light. The drug substance exhibits good stability when stored at -15°C to -25°C in an argon atmosphere. The material is stable at room temperature when dissolved in a vegetable oil derivative, containing antioxidants, such as is used in calcitriol soft gelatin capsules (19). 

This procedure, with a mobile phase of spectroquality heptane ethyl acetate methanol (70 25 5) is also useful for analyzing calcitriol in soft gelatin capsules. 

Capsules are of two types hard and soft gelatin capsules. The present chapter will focus on the extemporaneous filling of hard gelatin capsules. Generally, the soft gelatin capsules are not compounded extemporaneously. Therefore, they are not discussed in this chapter. 

The flow-through cell is applicable not only for the determination of the dissolution rate of tablets and sugar-coated tablets, but has also been applied to suppositories, soft-gelatin capsules, semisolids, powders, granules, and implants. A small volume cell containing the sample solution is subjected to a continuous stream of dissolution media. The dissolution... 

Figure 6 Different cell types for dissolution testing using the flow-through system. Type (a) tablet cell (12 mm), (b) tablet cell (22.6 mm), (c) cell for powders and granulates, (d) cell for implants, (e) cell for suppositories and soft gelatin capsules, (f) cell for ointments and creams.

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