Capsules until HGC

capsules

solid dosage forms in which medicinal agents and/or inert substances are enclosed in a small shell of gelatin

Elegance of use

Portability

Ease of use

Smooth and slippery for ready swallowing

Tasteless shell to mask unpleasant taste or odor of drugs

Advantage of capsules

KCl

KBr

NH4Cl

Capsules are not used for extremely soluble materials like

Not used for extremely soluble materials like KCl, KBr or NH4Cl as sudden release of drug may be irritating

They cannot be used for moisture-sensitive drugs

Not used for highly efflorescent or deliquescent materials

Disadvantages of Capsules

Efflorescent materials

Gives off water which many cause softening of capsule shell

Deliquescent materials

Takes in water from the gelatin shell and may dry the capsule shell rendering it brittle which leads to cracking of capsule

Cost of the shell

Slower production rates even with modern filling equipment

capsules are more expensive than tablet due to

granulation step

increased costs can be offset by avoiding

esophagus

capsules are larger than corresponding tablet formulations, potentially leading to retention in the

compressibility

there is a reduced requirement for this, and often the flow properties are not as critical as in an equivalent tablet formulation

capsules

can be employed when the active ingredient does not possess suitable compression characteristics

humidity

needs to be considered during manufacture and storage

moisture

this leads to stickiness

desiccation

this causes brittleness

hard gelatin capsules

soft gelatin capsules

types of capsules

dry-filled capsule

hard gelatin capsule is also known as

hard gelatin capsule

consists of 2 sections, 1 slipping over the other

gelatin

sugar

water

empty capsule shells are made of

gelatin

obtained by the partial hydrolysis of collagen obtained from skin, white connective tissue, and bones of animals

partial hydrolysis

gelatin is obtained by

collagen

gelatin is obtained by the partial hydrolysis of what

skin

white connective tissue

bones of animals

gelatin is obtained by the partial hydrolysis of collagen obtained from what

gelatin

is a generic term for a mixture of purified protein fractions obtained either by partial acid hydrolysis, type a, or by partial alkaline hydrolysis, type b, of animal collagen

partial acid hydrolysis

type a gelatin

partial alkaline hydrolysis

type b gelatin

porcine skin

type a gelatin is from what

animal bones

type b gelatin is from what

gelatin

can compromise a mixture of both types in order to optimize desired characteristis

bone gelatin

imparts firmness

porcine skin

provides plasticity

gelatin bloom strength

a test to measure the strength of a gel or gelatin. The test was originally developed and patented in 1925 by Oscar T. Bloom

Oscar T. Bloom, 1925

Gelatin bloom strength was developed and patented by who and when

bloom gelometer

determines the weight in grams required to depress a standard plunger in a 6.67% w/w gel under standard conditions

bloom strength and viscosity

major properties of interest for formulation of capsules

215-280

bloom strength used in capsule manufacturing

silica gel

clay

activated charcoal

common desiccants

desiccants

since gelatin capsules do not protect hygroscopic materials from atmosphere water vapor as well as moisture can diffuse through the gelatin wall, a small packet of what is included in the package of capsules

15-18%

Moisture content of empty hard capsule

30-50%

handling of empty hard capsule should be with humidity around what?

colorants

opacifiers

preservatives

often paraben esters

in addition to gelatin, the hard gelatin shells may contain

000

largest size of hard capsule for human use

5

smallest hard capsule for human use

0

largest capsule size considered suitable for oral use

65 mg to 1 g

HGC can encapsulate how many of powdered material

lactose

common diluent in hgc

MgCO3

Kaolin

Magnesium Oxide

For eutectic mixtures, absorbents like these are required

Diluents

Binders

Disintegrants

Surfactants
Glidants
Lubricants

Dyes

Colorants

Capsule excipients are similar to those required for formulation of tablets and include

Hydrogenated Peanut Oil

Castor Oil

Hydrogenated Castor Oil

Fractionated coconut oil

corn oil

olive oil

hydrogenated vegetabe oil

silicone oil

soya oil

liquid excipients compatible with hgc, peanut oil

cetyl alcohol

cetostearyl alcohol

stearyl alcohol

stearic acid

beeswax

silica dioxide

polyethylene glycols

macrogol glycerides

poloxamers

liquid excipients compatible with hgc, paraffin oil

HPMC (V-caps, Quali-VC, Vegicaps)

Pullulan Shells
Starch

Alternative for non-animal derived products in formulation of the capsule shells to address cultural, religious, and dietary requirements

Pullulan shells

naturally occurring fungal polysaccharide produced by fermentation of liquefied cornstarch (NPCaps)