Capsules hard gelatin

In addition to the tamper-evident packaging feature described in paragraph (b)(1) of this section, any two-piece, hard gelatin capsule covered by this section must be sealed using an acceptable tamper-evident technology. 

Filled hard gelatin capsules are held together by interlocking bumps and grooves molded into the cap and body pieces, and the capsules are usually additionally sealed by a banding process, which places a narrow strip of gelatin around the midsection of the capsule where the two pieces are joined. 

Hard gelatin capsules are uniquely suitable for blinded clinical tests and are widely used in preliminary drug studies. Bioequivalence studies of tablet formulations may be conveniently blinded by inserting tablets into opaque capsules, often along with an inert filler powder. Even capsule products may be disguised by inserting them into larger capsules. 

Fig. 1 View of a hard gelatin capsule manufacturing machine. (Courtesy of Elanco Qualicaps, formerly a Division of Eli Lilly Co., Indianapolis, IN)... 

The largest size normally acceptable to patients is a No. 0. Size 0 and size 00 hard gelatin capsules having an elongated body (e.g., 0E and 00E) also are available that provide greater fill capacity without an increase in their respective diameters. Three larger sizes are available for veterinary use Nos. 10,11, and 12, having approximate capacities of 30, 15, and 7.5 g, respectively. 

Hard gelatin capsules are made self-locking by forming indentations or grooves on the inside of the... 

Hard gelatin capsules may be made hermetically sealed by the technique of banding wherein a film of gelatin, often distinctively colored, is laid down around the seam of the cap and body. Parke Davis KapsealR is a typical example. In the Quali-SealR process (Shionogi Qualicaps), two thin layers are applied, one on top of the... 

Finished hard gelatin capsules normally contain an equilibrium moisture content of 13-16%. This moist-... 

G. Design of Hard Gelatin Capsule Formulations for Powder Fill... 

This section addresses the design of immediate-re-lease powder formulations for hard gelatin capsules. In general, powder formulations for encapsulation should be developed in consideration of the particular filling principle involved. The requirements imposed on the formulation by the filling process, such as lubricity, compressibility and/or compactibility, and fluidity can vary between machine types. Furthermore, the... 

Fig. 19 Effect of disintegrants on hydrochlorothiazide dissolution from hard gelatin capsules (filler, dicalcium phosphate lubricant, 1% magnesium stearate). (From Ref. 132.)...

Another approach to improving the wettability of poorly soluble drugs is to treat the drug with a solution of a hydrophilic polymer. Lerk et al. [137] reported that both wettability of the powder and the rate of dissolution of hexobarbital from hard gelatin capsules could be greatly enhanced if the drug were treated with methylcellulose or hydroxyethylcellulose. In this process, called hydrophilization, a solution of the... 

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]. 

IV. SOFT/LIQUID-FILLED HARD GELATIN CAPSULES... 

BE Jones, TD Turner. A century of commercial hard gelatin capsules. Pharm J 213 614-617, 1974. 

LC Lappas. The manufacture of hard gelatin capsules, paper presented to Research and Development Section, The American Drug Manufacturers Association, Atlantic City, NJ, October 8, 1954. 

BE Jones. Hard gelatin capsules and the pharmaceutical formulator. PharmTechnol9(9) 106-108,110,112,1985. 

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