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Y2 - DFDM1 > Materials and Excipients II > Flashcards

Materials and Excipients II Flashcards

1
Q

What else is included in addition to API in tablet formulations?

A

Coated in sugar - Palatability

Fillers - Inc size

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2
Q

What else is included in addition to API in solution formulations?

A

Water, flavour, sweeteners - Palatability

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3
Q

What else is included in addition to API in topical formulations?

A

Water, Viscose (enhancer) - To easily spread

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4
Q

What else is included in addition to API in IV formulations?

A

Water, salts - Isotonic salt level balance compared to bloodstream

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5
Q

What is used to provide bulk to formulations?

A

Fillers or diluents

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6
Q

What should fillers be?

A

Inert (non-reactive), non-toxic, stable, cheap, good mechanical properties eg hard, tough

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7
Q

Give an example of common diluents

A

Lactose and calcium salta

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8
Q

Give examples of formulations containing fillers

A

Granules, tablets, powder-filled capsules

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9
Q

Define disintegrants

A

Materials that aid breakdown of solid dosage forms

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10
Q

How do disintegrants work?

A

Expand on contact with water, aid uptake of water

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11
Q

Examples of formulations containing disintegrants

A

Tablets, effervescent tablets, powder-filled capsules

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12
Q

Define lubricants

A

Added to tablets/capsule plugs to stop dosage form sticking to machinery

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13
Q

Define glidants

A

Added to powder to aid flow

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14
Q

Define binders

A

Polymer solutions in water aid adhesion of powders to form granules

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15
Q

Define vehicle/base and give examples for IV, gels, suppositories

A

Liquid or semi-solid which a drug is contained eg:
IV - water/oil base (sc/im)
Gels - water, oils
Suppositories - fatty triglycerides

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16
Q

Define thickener/viscosifiers

A

Enhance viscosity of liquid formulation (usually hydrophilic polymers) eg for topical gels

17
Q

Define solubility enhancers and give examples

A

Improve solubility of drug in solvent eg surfactants, co-solvents

18
Q

What are organoleptic properties?

A

Fragrance, colourants (act as warning), sweeteners, flavourings

19
Q

How is stability ensured in drugs?

A

Using antioxidants and preservatives

20
Q

Define antioxidants

A

Slow down oxidation process, stop reactions with O2

21
Q

Define preservatives

A

Stop growth of microbes, enhanced shelf life and kill bacteria

22
Q

What can excipients impact?

A

Quality, Efficacy, safety of medicines

23
Q

Define friability (Quality)

A

Testing the durability of the tablets during transport, placed in a spinning machine to see effect of transport to tablet coating

24
Q

How are excipients regulated?

A

Approval needed, depending on difference between new/existing products

25
Q

How can you check the quality standards of excipients?

A

Excipients already in use have pharmacopoeial monographs that set standards

26
Q

What are the regulatory requirements for general products?

A

Parenteral, ophthalmic, oral: Contain same excipients in same conc as reference

27
Q

What are the regulatory requirements for other ROA?

A

No requirements excipients in final form be same as ref but must show inactive excipients doesn’t affect safety/efficacy of drug

28
Q

What are the regulatory requirements for new drug applications (NDA)?

A

Marketed pursuant to biologics license application (BLA) supported by data

29
Q

When would a NDA be approved?

A

If excipients better than historic ones or perform new functions (need to be vital to justify costs)

30
Q

Describe the example of B-cyclodextrin case study

What it’s used for and how it functions

A

Drug used to enhance water sol of poorly soluble drugs

Put dex in solution, add poor sol drug it moves to centre forming hydrophobic interactions and solubilises in centre

31
Q

What is a disadvantage of cyclodexrins?

A

Limited solubility (18mg/ml) - Limits how much drug can be dissolved in centre before dissolving itself

Y2 - DFDM1 (16 decks)

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