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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5320_Библиотеки_им_академика_М_И_Перельмана
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376
Pharmaceutical Dosage Forms and Drug Delivery
21.2.1.2 Comparison with Soft Gelatin Capsules
Compared to soft gelatin capsules, the manufacturing process of hard gelatin capsules is less demanding,
encapsulation of the drug formulation.
21.2.2 Solid- Filled Hard Gelatin Capsules
21.2.2.1 Main Applications
be opened.
21.2.2.2 Formulation Considerations
1. Flow
2. Density
3. Lubricity
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4. Compactibility
Noninteraction with capsule shell-
6. Dose
7. Particle size, shape, and density
8. Moisture sorption– desorption isotherm: Moisture sorption and retention properties of the drug
9. Solubility and wettability
377
21.2.2.3 Formulation Components
1. Fillers (or diluents
of the formulation.
2. Glidants
a.
b. Reducing attractive forces.
c. Reducing electrostatic repulsion.
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Pharmaceutical Dosage Forms and Drug Delivery
3. Lubricants
stearic acid.
4. Surfactants and wetting agents
their capsule formulations.
Disintegrants
contents. Common disintegrants used in hard gelatin capsule formulations include croscarmellose
21.2.2.4 Manufacturing Process
As illustrated in Figure 21.3
1.
2.
3.
the lever and inverting the base plate.
•
•
for tableting.
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Capsules
FIGURE 21.3
379
•
1. dosator device
2. tamping device
21.2.3 Liquid- and Semisolid- Filled Hard Gelatin Capsules
21.2.3.1 Main Applications
in vivo
®, are available in various
®
can increase the effectiveness of environmental protection in the capsule dosage form.
.
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TABLE 21.2
Pharmaceutical Dosage Forms and Drug Delivery
Active
Formulation Type
capsules
Amphetamine and
Didanosine
hard gelatin capsules
Captopril Captopril- R
Ibuprofen Solufen Pain
Solicam SMB Arthritis
Soft gelatin capsules Saquinavir Fortovase Roche
Dutasteride Avodart Benign prostate
Immunosuppressant
Progesterone Prometrium Abbott
Ingredient(s) Brand Names Manufacturer Indications
Cinobac
infection
Shire Pharmaceuticals
disorder
disorder
Colitis
21.2.3.2 Formulation Considerations
gelatin capsules:
1. Noninteraction with capsule shell -
2. Dose
into a hard gelatin capsule.
3. Hygroscopicity
the hard gelatin shell.
21.2.3.3 Formulation Components
1. Triglycerides
®
olive oil, and corn oil.
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381
2. Surfactants
enhancers, such as Cremophor®®®®.
3. Cosolvents
21.2.3.4 Manufacturing Process
1.
banding because a band of gelatin is formed on the outside of the capsule.
2.
sealing
21.3 Soft Gelatin Capsules
21.3.1 Advantages and Disadvantages of Soft Gelatin Capsules
enteric coated.
effect on the gelatin.
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21.3.2 Drivers for Development of Soft Gelatin Capsules
Pharmaceutical Dosage Forms and Drug Delivery
1. Line extension
2. Technological advantages
3. Safety
4. Improved oral bioavailability
the presentation of the drug in a predissolved state can lead to a shorter duration to a the onset of
21.3.3 Formulation of Soft Gelatin Capsule Shell
1. Gelatin
•
•
and reproducible strength.
TABLE 21.3
Component Function Typical Content (% w/ w)
66.3
33.0
20 ratio)
Color Colorant 0.1
Solvent/ process aid
Preservative 0.1
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-
2. Plasticizer-
ture (T g
3. Water
4. Preservative
Colorant and/ or opacier
to the shell for visual appeal and/ or to reduce the penetration of light for the encapsulation
that of its contents.
6. Other excipients
383
21.3.4 Drug Formulation for Encapsulation in Soft Gelatin Capsules
® is a suspension of isotretinoin
in oil, Sandimmune® ®
preconcentrate.
• Noninteraction with gelatin
gelatin shell.
• Nonmoisture sensitivity
• Nontemperature sensitivity
• pH
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Pharmaceutical Dosage Forms and Drug Delivery
21.3.5 Manufacturing Process
in Figure 21.4
1.
spreader box.
2. oil rolls that stretch the sheets and direct them approdie rollers.
FIGURE 21.4 Manufacturing process of soft gelatin capsules. (Adapted from .)
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Capsules
3.
the rollers.
4. As the gelatin sheets are being annealed, a calibrated amount of the drug formulation is pumped
product pump through an injection wedge.
Figure 21.4
separate, subsequent operation.
6.
7.
labeling.
21.3.6 Nongelatin Soft Capsules
®
21.4 Evaluation of Capsule Drug Products
1.
guide to alter the manufacturing- process parameters.
2.
3.
21.4.1 In- Process Tests
•
•
•
•
•
-
atin capsules.
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