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QP - the reprise > Formulation and Processing > Flashcards

Formulation and Processing Flashcards

1
Q

What are typical softgel capsule IPCs

A

ribbon thickness
softgel seal thickness at time of encapsulation
Fill matrix weight and capsule shell weight
Softgel moisture level
hardness at end of drying

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2
Q

What are the compendial requirements for unit dose capsule products?

A

appearance
assay
fill weight
content uniformity
disintegration
micro

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3
Q

What are the advantages of softgel capules?

A

improved rate and extent of drug absorption (esp water insoluble drugs)
Easy to swallow & lack of taste = patient compliance
Safety of operators – no dust
can do apis that can’t do with tablets or normal capsules
dose uniformity for high potency – liquid = automatically homogeneous
stability as drugs are protected by the capsule shell

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4
Q

Summarise how softgel capsules are made

A

Gelatine melted (80°C) with glycerol plasticiser and formed into a ribbon. As it passes over the rotating dies, the liquid contents are injected, which pushes the ribbon into the pockets. As the roller rotates, it seals the pockets and then cuts them into caplsules. These are dried in a linked tumble tunnel dryer initially and then onto trays for up to 14 days.

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5
Q

What is impact of a cream being too hard?

A
  • This can be straight after manufacture or on standing
  • Causes filling problems
  • Poor setting up of the filling machine can lead to this being incorrectly blamed as the cause of filling problems
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6
Q

What is the impact of a cream being too soft?

A
  • Noticeable immediately after manufacture
  • Occurs with creams rather than ointments
  • Causes “Tailing” to occur on filling machines and product to be found in crimps
  • Poor setting up of the filling machine can lead to this being incorrectly blamed as the cause of filling problems
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7
Q

Talk to me about product aeration in semi-solids

A
  • Can occur with both creams and ointments
  • Causes filling problems
  • Poor setting up of the filling machine can lead to this being incorrectly blamed as the cause of filling problems
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8
Q

What is bleeding? Wrt semi-solids

A

This is the name given to the appearance of oily droplets on the surface of some ointments

Ointments containing propylene glycol are the biggest problem I.e. Propaderm and Dermovate

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9
Q

What and why is creaming / cracking?

A
  • This only occurs with creams (2 phase systems)
  • Cracking is the complete and irreversible separation of the oil and water phase
  • Creaming is the accumulation of oil droplets at the top of the product (reversible)
  • Potential causes insufficient mixing and combining phases at significantly different temperatures
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10
Q

Why might you get physical contamination in a tube of cream?

A

Metal swarf may be present in the tubes

Might get a reaction with the aluminium if the inner laminate has pin holes and reacts with the aqueous phase of the cream

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11
Q

What are the Problems caused by microbiological contamination with a cream

A
  • Risk of microbiological infection
  • Reduction in active ingredient levels
  • Physical changes to dose form

– Carbohydrates may be metabolised to acids which may
* form odours
* Change pH
* Form colours

– Thickeners may be metabolised and change the physical properties of the product

– Changes to pH may lead to separation of phases

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12
Q

What are the typical CPPs with a cream?

A

Mixing time
Agitator speed,
Homogeniser speed
Pressure / Vacuum
Jacket temperature
Product temperature – both mixing and discharge
filling speed.

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13
Q

What are the facility consideration for a cream?

A

Flooring – equipment heavy and needs to be resistant to spills of hot fat and oil. Need to be non-slip

Micro – products are often susceptible to micro contamination and need protecting

Equipment – large vessels of hot liquid – viscous for pumping, high shear mixers for homogenising, ATEX. Vessels need vacuum (pull of air to help fill) and pressure (used to transfer product)

Cleaning – CIP. Need to skim fat off to minimise amount down drain – need fat separator in drain

HVAC – class D unless sterile

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14
Q

What are the advantages of cream preparations?

A
  1. Easy to wash.
  2. Not greasy.
  3. Cream base contain large amounts of water so that can increase the release of the drug.
  4. The surface tension of the skin will be lowered by the emulsifiers so that absorption is faster.
  5. The cream is easy to use, provides good drug dispersion on the skin surface.
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15
Q

What are the IPCs for tubes of cream?

A

a. Appearance of filled tubes (Batch variable information and leaks)

b. IPC fill weight testing

c. Expulsion (for creams)

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16
Q

What are the final lab tests for a cream?

A

a. Description
b. Active & preservative content
c. pH
d. Impurities & degradants
e. Microbiological
f. Weight of contents (Filled tubes)

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17
Q

What are the different herbal product categories?

A

Herbal Substances (HS)
Herbal Preparations (HP)
Herbal Medicinal Products (HMP)

18
Q

What’s the definition of a herbal substance?

A

mainly whole, fragmented or cut plants, plant parts, algae, fungi, lichen in an unprocessed, usually dried, form, but sometimes fresh

19
Q

How do you specify an herbal substance?

A

Herbal substances are precisely defined by the plant part used and the botanical name according to the binomial system (genus, species, variety and author).

20
Q

What’s a herbal preparation?

A

preparations obtained by subjecting herbal substances to treatments such as extraction, distillation, expression, fractionation, purification, concentration or fermentation.

21
Q

What’s a Herbal medicinal product?

A

any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations

22
Q

What are the conditions associated with being a “Traditional Herbal Product” (article 16a (1) of Directive 2001/83/EC)

A

– Limited indications e.g. treatment of coughs, aches and pains, mild anxiety

– oral, external or inhalation preparations

– At least 30 years documented traditional use, and at least 15 years use within the EU

– Long standing experience has proven product is not harmful and efficacy is probable

23
Q

Where would you find the definitions of traditional herbal product?

A

Part 7 2012/1916

article 16a (1) of Directive 2001/83/EC

24
Q

Herbal medicinal product that are traditional herbal products – what are the restrictions?

A

– Restricted to minor conditions appropriate for self-medication

– GSL category only (General Sales List – available for self selection on shelves)

25
Q

Herbal medicinal products – what sort of product and what needed for file?
What examples?

A

– can be either GSL, P, POM medicines

– can be used for any route of administration

– have to provide full CTD data on safety, quality and efficacy

– Sativex (oromucosal spray containing 2 extracts from Cannabis)

– Sennokot (tablets containing powdered Senna fruit)

26
Q

What are the ways of quantifying HMPs

A

Standardised extracts
– adjusted within an acceptable tolerance to a given content of constituents with known therapeutic activity e.g. senna assay is measured by the quantity of sennosides present.

– Quantified extracts
adjusted to a defined range of constituents; Assay is measured by the use of a ‘marker’ to calculate the amount of starting material in the finished product.

Other extracts are essentially defined by their production process (state of the herbal drug to be extracted, solvent, extraction conditions) and their specifications. The label claim states there is a certain quantity of Herbal Preparation in the Finished Product

27
Q

What are the Specifications for herbal substances (HS) linked to?

A

− Botanical characteristics

− Macroscopical and microscopical characters

− Phytochemcial characters or markers, toxic constituents (identity, assay, limit tests)

− Profile and stability of constituents

− Impurities (microbial levels, aflatoxins, heavy metals, pesticides, fumigants)

28
Q

What are the Specifications for herbal preparations (HP) linked to?

A

− Quality of HS

− Definition (drug extract ratio, extraction solvent)

− Constituents (analytical markers)

− Impurities (microbial levels, residual solvents)

− Profile and stability of the constituents

29
Q

What are the Specifications for herbal medicinal product (HMP) linked to?

A

Quality of HS and HP

Manufacturing process (residual solvents)
Profile and stability of the constituents / formulation – a series of product-specific, stability-indicating tests should be proposed to monitor quality during shelf life.

General tests are: Description, identification, assay, impurities (e.g. solvents in tablet coatings, degradation products), microbial limits.

There are specific tests for tablets (coated and uncoated) and hard capsules, oral liquids and HMP containing exclusively herbal substances (e.g. Herbal teas).

30
Q

What are the excipient types in a tablet

A

Diluent
Disintegrant
Solution Binder
Dry binder
Glidant
Lubricant
Anti-adherent

31
Q

What are examples of diluent

A

Lactose
Mannitol
Microcrystalline cellulose

32
Q

What are examples of disintegrant

A

SSG
Cellulose

33
Q

What are examples of solution binder

A

Polyvinylpyrrolidone (PVP) - Povidone to you and me
Hpmc
Starch

34
Q

What are examples of dry binder

A

PEG
Cellulose

35
Q

What are examples of glidant

A

Silica
Talc
MgSt

36
Q

What are examples of lubricants

A

MgSt
PEG
SSF = sodium stearyl fumarate

37
Q

What are examples of anti-adherent

A

MgSt
Talc
Starch

38
Q

Name different sorts of tablets

A

Chewable
Effervescent
Compressed lozenges – suck and dissolve API in spit
Sublingual and buccal – in through tounge / cheek with no first pass
Prolonged release

39
Q

What test needed to demonstrate breakline?

A

Tested development or validation

30 tablets snapped and one half taken of each
Weigh them
Not more than one outside 85-115% or if one is outside 75-125%

40
Q

What’s pharmacognosy?

A

The use of natural components in pharma.

The steps commonly taken in the manufacture/preparation of active substances and excipients of natural origin including their purpose and limitations

QP - the reprise (14 decks)

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