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Chemistry > Pharmaceutics > Flashcards

Pharmaceutics Flashcards

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1
Q

What is a drug?

A

Active pharmaceutical ingredient

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2
Q

How long does a standard patent last?

A

About 20 years, can be extended by additional 5 years

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3
Q

How long does it normally take for a drug to get to clinical trials//to identify its toxicity?

A

6 years

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4
Q

How long does the process ‘new drug application’ take before that drug go onto the market?

A

Normally takes 2 years for the government to approve

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5
Q

How long does it take for a drug to develop, file a new drug application and obtain market authorisation (MA)?

A

10-15 years

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6
Q

What’s the objective of pharmaceutical R&D industry?

A

Convert synthesised chemical compounds into candidate drugs for development

Product development: converting candidate drugs into dosage forms for registration and sale.

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7
Q

What are the 4 phases of a pipeline?

A

Discovery, pre clinical, clinical trials and marketing

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8
Q

What is a pipeline?

A

A set of new drug candidates that are to be developed (NCE- New chemical entities)

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9
Q

What does it mean by formulation of a drug?

A

The process in which APIs and excipients are combined to produce a medicinal product.

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10
Q

What’s a generic drug?

A

A drug which is bioequivalent to a leading brand name ( same pharmaco kinetic/ dynamic properties)

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11
Q

Define system (in term of thermodynamics)

A

The part of universe with which we are studying

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12
Q

Define surroundings

A

The rest of the universe

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13
Q

What are the three types of system?

A

Open // close // isolated

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14
Q

Define open system

A

Both matter and energy (heat) can be exchanged with the surroundings

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15
Q

Define closed system

A

Contains a fixed amount of matter but allows exchange of heat

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16
Q

Isolated system

A

There’s no exchange of heat or matter with the surroundings

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17
Q

What is a medicinal product?

A

The presentation of a drug in a dosage form suitable for administration to the public I.e. A formulation

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18
Q

What’s a brand name?

A

Given by pharmaceutical R&D (research and development) company and is a registered R name.
Has a trade marks: for manufacture to identify their own goods, to indicate the source of goods.

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19
Q

What’s a chemical name?

A

Name for the API chosen by an expert committee

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20
Q

What’s a trademark?

A

A trademark is any word, name, symbol, or design used in commerce to identify and distinguish the goods of one manufacturer/ seller to another and to
Indicate the source of goods.

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21
Q

How long does trademark last?

A

As long as trademark is used in commerce and defended against infringement (copycat)

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22
Q

What does the pharmaceutical R&D do?

A

Convert chemical compounds into candidate drugs for development

Convert drug into dosage forms for registration and sale.

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23
Q

Why is pharmaceutical sale biggest in the US?

A

Medicines are more expensive in the US.

More people in the US

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24
Q

What’s a blockbuster?

A

A blockbuster drug is where slows reach over US £1 billion per annum

25
Q

What can fracture market?

A

If the companies concentrating on specific ailments/ therapies. (More people can buy the drug so bigger profile (which company wants) whereas the genomics and personalised medicines- work with people’s genes cost more in development and don’t gain as much profit)

26
Q

What’s ROI?

A

Return of investment

27
Q

What aspects does generic drug have to be same as the brand name drug?

A

Dose, route of administration, safety and efficacy

28
Q

Why is use of generic drug has a lower cost?

A

No investment in R&D into new drugs

Bio Equivalence testing and manufacturing costs are relatively low

29
Q

What’s/ where is the regulatory approval process carried out in the USA?

A

Center for Drug Evaluation and research (CDER) at the FDA (federal drug agency)

  • NDA new drug application
  • ANDA abbreviated new drug application
30
Q

What’s the regulatory approval process in Europe?

A
  • NP nationalised process
  • CP Centralised process
  • DCP decentralised process
  • MRP mutual recognition process
31
Q

Why is generic medicine are encouraged to be prescribed?

A

Generic medicines are equally effective and customers/ store can save up to 80% on the cost of a branded product.

Allow pharmacist the widest choice of product

Important if there is a shortage of a particular product

32
Q

What types of medicine have to be prescribed as generic with caution?

A

EMLB
1) epilepsy medicines- slight differences in rate of absorption may cause a big difference in therapeutic effect

2) modified release preparations- different way of absorption
3) lithium- absorption may vary widely from brand to brand, and also how medicine becomes active.
4) biological molecules- copies of these complex medicines (biosimilars) may not be automatically used as a substitute. Doc has to reference specific manufacturer. (Give manufacture increased pricing power due to complexity of biosimilars)

33
Q

The difference and similarity of chemical generic and biosimilars?

A

Difference: chemicals can be copied quickly and low cost (2-3 years,$2-5 M)

Complex biological takes longer & cost more to copy (>5 years, $100M)

Similarity: lower initial investment means greater savings
Avg saving for- chemical 75%
-biological 20%

34
Q

What’s dosage form?

A

Dosage forms are the means by which drug molecules are delivered to sites of action within the body.

35
Q

An excipient should be…?

A

Chemically and physiologically inert, safe

36
Q

Why do people might have moral or religious problem with excipients?

A

Gelatin

37
Q

Why use excipients?

A

AASI

Aid processing of the system during manufacturing and accurate dose control

Control rate of absorption

Protect, support or enhance stability,bioavailability, solubility

Assist in production identification

Enhance the overall safety and effectiveness of drug during storage and use

38
Q

Describe a syrup

A

A concentrated aqueous solution of sugar, usually sucrose.

Flavoured to mask unpleasant taste

39
Q

Describe an elixir

A

A sweet clear liquid oral preparation of potent or nauseous drugs

Contain a high proportion of ethanol in purified water and sucrose, together with anti microbial preservatives- ensure stability

40
Q

Describe a linctus

A

A viscous liquid -used for couch relief
Contains high level of glycerol and syrup
Dose volume is small

41
Q

Describe an oral drops

A

Liquid preparation
Small dose volume
Used with a suitable measuring device
Maybe solutions, suspension or emulsion

42
Q

Describe an ointment

A

Viscous, greasy, topical
80% oil 20% water
Immiscible with skin secretions

43
Q

Describe a cream

A

Can be O/W or W/O
O/W: aqueous, more comfortable, easily wash off using water, less greasy

W/O: drug normally hydrophobic
Oily, more moisturising- oil barrier reduce water loss from stratum corneum

44
Q

What’s the advantage of transdermal patch?

A

It provides a controlled release of the medications into patient

45
Q

What’s suppositories/ pessaries?

A

Solid dosage form of medicine intended to dissolve in rectum/ vagina/ urethra
However the quantify of fluid available for drug dissolution in the rectum is VERY SMALL

46
Q

What are the 4 types of parenteral injections?

A

IM eg vaccines
Subcutaneous (FAT) eg insulin
IV
Intradermal (dermis)

47
Q

What are the three formulations inhaler can be prepared as?

A

Solutions, suspensions, dry powder

48
Q

What are the three classes of medical inhalation devices?

A

Pressurised MDIs
DPI -dry power inhalers
LDIs- liquid dose inhalers/ nebulisers

49
Q

What are the four location where dry power inhalers are target to deposit?

A 
Trachea 
Lobar bronchus 
Terminal bronchioles 
Alveolar duct 
Diameter in mm - particle diameter in micro m
50
Q

What are the 4 advantages of local drug delivery? SARA

A

Drugs delivered directly to site of action

Drug action onset is rapid

Less drug in systemic circulation

Smaller doses (A) required Than oral route

51
Q

2 types of ophthalmic formulation, explain each

A

Eye drops- saline containing drops administered in the eye. May contain steroids, antihistamine, topical anaesthetics.
Can be non-medical- used to lubricate as a tear replacing solution.

Eye ointment (ophthalmic ointment)- semi solid preparation, apply to conjunctiva or eyelid margin

52
Q

What are the 3 formulations of Otis dosage form can be?

A

Solution suspension emulsions

53
Q

What device is used when using ear drop?

A

A dropper

54
Q

What ear drop is used for?

A

To treat ear infections especially of the outer ear and ear canal

55
Q

Describe a solution

A

Clear liquid preparation

Contains one or more API dissolved in a solvent - can be diluted alcohol glycerin, purified water

56
Q

What’s an emulsion?

A

Stabilised oil in water dispersion may contain dissolved solids

57
Q

What are the three most common type of excipient used?

A

1) diluents (compressible bulking agents), binders- things that ensure efficient tabletting
2) disintegrants to ensure the tablet breaks up in the GIT
3) sweeteners or film coating for taste to mask taste of API

58
Q

What are the three most common type of excipient used?

A

1) diluents (compressible bulking agents), binders- things that ensure efficient tabletting
2) disintegrants to ensure the tablet breaks up in the GIT
3) sweeteners or film coating for taste to mask taste of API

59
Q

What’s non electrolyte?

Examples?

A

Compounds they do not ionise in solution, and do not conduct electricity (current) through solution

Sucrose 
Glycerin
Urea
Steroid 
Naphthalene

Chemistry (3 decks)

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