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Pharm303 > Solid Dosage Forms - Capsules > Flashcards

Solid Dosage Forms - Capsules Flashcards

0
Q

What are the limitations of hard gelatin capsules?

A

High speed manufacturing is slower

Too rapid release of highly soluble salts can cause gastric irritation

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1
Q

What are the advantages of hard gelatin capsules?

A

Assumed to have better bioavailability
More flexible in formulation
Possible to fill diverse ingredients
Suitable for clinical trials

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2
Q

What factors associated with the formulation of liquid filled gelatin capsules affect the bioavailability?

A

The solubility of the drug in the vehicle and GIT
The particle size of the drug if suspended in the vehicle
The nature of the vehicle i.e. Hydrophilic or lipophilic
The inclusion of a surfactant such as a wetting/emulsifying agent in a lipophilic vehicle or as the vehicle itself
The inclusion of a suspending agent (viscosity enhancing agent) in the vehicles.
The complexation i.e. Formation of non absorbable complex between the drug and any excipients added

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3
Q

What formulation factors of hard gelatin capsules (filled with powder) affect its bioavailability?

A

Surface area and particle size of the drug particularly the effective surface area exhibited by drugs in the GI fluids
The use of the salt form of drug in preference to the parent weak acid or base
Crystal or amorphous form of the drug
Chemical stability of the drug in the dosage form and in the GIT.
Nature and quantity of the diluent, lubricant and wetting agent
Drug-excipient interactions e.g. Adsorption or complexation
Composition and properties of the capsule shell including enteric capsules
Interactions between the capsule shell and its contents
Type and conditions of the filling process

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4
Q

How are hard gelatin capsules manufactured?

A

By hydrolysis of collagen which is the main protein constituent of connective tissues.

Used animal skin and bone for manufacture.
The collagen is extracted using hot water and concentrate.
It is then chilled to form a gel, dried, graded and then blended to get the required characteristics.

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5
Q

What is the difference between type a and type b hydrolysis?

A

Type a is acid hydrolysis

Type b is basic hydrolysis

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6
Q

What are the important characteristics of a gelatin capsule?

A

Bloom strength - this is a measure of gel rigidity
Hard capsule has a bloom strength of 200-250g and soft capsules have a bloom strength of 150g
Viscosity

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7
Q

What are non gelatin capsules?

A

Produced in response to religious, cultural and vegetarian needs.
Materials include starch and hydroxypolymethylcellulose

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8
Q

What are other raw materials involved in the formulation of gelatin capsules?

A

Water soluble dyes (e.g. Erythrosine, indigo carmine, quinolone yellow)
Insoluble pigments (e.g. Iron oxides, titanium dioxide which is white/opaque)
Processing aids (like wetting agents such as sodium lauryl sulphate 0.15%, preservatives)
Water

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9
Q

How are gelatin capsules manufactured?

A

Metal moulds at room temperature are dipped into a hot gelatin solution.
The gel forms a film
This is dried, cut to length and removed from the moulds.
The two parts are joined together.

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10
Q

What are the gelatin capsule properties?

A

Moisture content between 13.0-16.0% w/w these will vary with environmental conditions.

Readily soluble in water at 37.0°C
Insoluble below 30°C

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11
Q

What are the effects of humidity on the moisture content of the capsule and why is it significant?

A

A low humidity results in a loss of moisture causing the capsule to become brittle.
A high humidity results in a gain of moisture causing the capsule to soften

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12
Q

Why should gelatin capsules be insoluble below 30°C?

A

Below this temperature capsules will absorb water and distort

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13
Q

What are the 4 different sizes of capsules?

A 
000 (largest)
00
0
1
2
3
4
5
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14
Q

How big is the largest available capsule size?

A

Size 000 is about 23.5mm

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15
Q

How big is the smallest capsule size?

A

Size 5 is about 12mm

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16
Q

What are the modifications to the capsule shell?

A

I.e. The snap fit principle.

A tapered rim which prevents faulty joins
Indentations under the rim which prevent the pre closed capsule from opening too early.
Lock grooves on both halves of the capsule to lock the two halves together after filling

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17
Q

What are the steps involved in capsule filling?

A 
Rectification
Separation
Dosing of fill material
Cap replacement
Ejection of filled capsules
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18
Q

What is used for powder and granule filling on the bench scale?

A

Tevopharm,
Contains plastic plates with holes. Capsules are oriented, the lids re removed, they are filled with the powder and then the lid is replaced.
Can use a checkweigher to screen

19
Q

What is used to fill capsules with powder and granules on the industrial scale?

A

A dosing system.
Either dependent on capsule body like an auger type or independent on capsule body.
This fills 5,000-15,000 per hour

20
Q

What does an independent dosing system do?

A

A soft compact plug formed at low compression forces and emptied into the shell

21
Q

What are the two types of independent dosing systems?

A

Do stores

Tamping fingers

22
Q

What is a dosator?

A

A dosing tube with a moveable piston which can be adjusted to change the dosing volume

23
Q

How does a dosator work?

A

The tube is lowered into the powder bed to form a powder plug
Compression force can be applied to further consolidate this plug
The tube is raised over the powder need and ejected into the capsule body
Weight of fill can be adjusted

24
Q

How can the weight of fill be adjusted?

A

By changing the volume via the piston

By changing the depth of the powder bed

25
Q

What factors of the capsule filler is related to filling?

A

Good flow
No adhesion
Cohesion

26
Q

What is the benefit of encapsulating a low dose drug?

A

The factors related to filling such as good flow no adhesion and cohesion of the drug is easier to obtain for a low dose drug

27
Q

What are the properties of the mixture of larger doses governed by?

A

The properties of there active ingredient

28
Q

What are the excipient and formulation strategies of capsules similar to?

A

That of powder formulation for tableting.

29
Q

What are soft gelatin capsules?

A

Consist of liquid or semi solid matrix inside a one piece gelatin shell.
Can be solid at room temperature, provided it is semisolid below 45°C

The drug may be in solution or suspension

30
Q

What are the different types of fill matrices of soft gelatin capsules ?

A

Hydrophilic (e.g. PEGs)
Lipophilic e.g. Triglyceride vegetable oils
They may also be mixture

31
Q

What is the rationale for soft gelatin capsule use?

A

Oil and low MP drugs
Improved drug absorption for poorly water soluble drugs (dispensed as lipid soluble)
Patient compliance and preference as soft gels are easier to swallow, have no taste and is more convenient
Safety - avoiding Duse as active components are liquid
Dose uniformity for low dose drugs
Product stability

32
Q

What are the components of soft gelatin capsule shells?

A

Gelatin 40% of mass
Water 30-40% of mass
Plasticizer 20-30% of mass
May be coated either with enteric coating or to achieve delayed release

33
Q

What are the different types of soft gelatin formulations?

A

lipophilic liquids/oils (including triglyceride + vegetable oils e.g. soy bean oil)
Hydrophilic liquids (Polyethyleneglycol 400)
self emulsifying oils
microemulsion and nanoemulsion systems (preconcentrate of appropriate ingredients and proportion will form microemulsion when in contact with GI i fluids)
Suspensions (suspensions will require small particle size to ensure that filling pump is not blocked.)

34
Q

What are the 3 different methods of manufacturing soft gels?

A

Plate process
Rotary die process
Bubble method

35
Q

What is the rotary die process?

A

4 main parts:

1) pre-encapsulation processes which includes the manufacture of the gelatin mass and the fill matrix
2) preparation of two gelatin ribbons
3) encapsulation which includes the formation of the heat seal between the two gelatin ribbons as well as the simultaneous dosing of liquid fill into each capsule.

The capsule is then dried.

36
Q

What are the main components of the rotary die?

A 
Wedge
Gel ribbon
Waste gelatin
Soft gels
Die roll
Fill material
37
Q

What does soft gel in process testing include?

A 
Gel ribbon thickness
Soft gel thickness at time of encapsulation
Fill matrix weight
Capsule shell weight
Shell moisture content
Shell hardness at end of drying
38
Q

What is part of soft gel finished product testing?

A

Appearance
Active ingredient and related substances assay/content uniformity
Microbiological testing
Dissolution

39
Q

What is the shell polymer of non gelatin or vegetarian capsules?

A

Hydroxypropylmethylcellulose, starch

40
Q

What are the advantages of vegetarian capsules?

A

Satisfies religious and cultural needs
Low moisture content make HPMC non animal capsule suitable for hygroscopic materials.

Preservative free

41
Q

What quality control test just be conducted on capsules?

A

Disintegration time
Uniform of filling weight
Content of medicament

42
Q

How is disintegration time of capsules tested?

A

Uses same apparatus as tablets
Necessary to distinguish particles of shell and the drug during the test
Standards as per the pharmacopoeias

43
Q

How is uniformity of filling weight determined for capsules?

A

Cannot be determined simply by weighing the fill capsules as the empty shells may vary in weight.

The weight of the content of an individual capsule is defined as the difference in the weight of an intact dose unit and the empty shell.

If contents are oily, this must be squeezed out of the caspule and the shell must be washed with a suitable solvent.

Standards as per the pharmacopeias

44
Q

How is the content of medicament in each capsule tested?

A

By conducting a drug assay per capsule.

The bulk contents of the required number of capsules is assayed and is compared to the standards as per the pharmacopoeias

Pharm303 (15 decks)

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