Pharmaceutical Materials Flashcards

1
Q

Parts of a drug

A

Active ingredient and excipients

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2
Q

Properties of a solid dosage formulation depend on …..

A

Chemical composition and solid structure of both drugs and excipients

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3
Q

What does using a different solid form of the same drug do

A

Alters the bioavaliability of the drug
Alters the stability of dosage forms
Influence the way in which the dosage forms can be processed and manufactured
Important for the regulatory control of drugs and dosage forms

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4
Q

Bioavailability defition

A

% of dosage that enters the systemic circulation

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5
Q

A drug must be in .. before it can cross the GIT wall

A

Solution

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6
Q

Different physical forms may have different:

A

Stabilities, chemical reactivities, flow, compression and water sorption properties

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7
Q

Molecule?

A

Entity containing a number of atoms held by covalent bonds

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8
Q

Particle?

A

Microscopic structure containing millions of molecules held by non-covalent bonds

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9
Q

Powder?

A

Visible mass of particles

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10
Q

Crystalline materials

A

Ordered, periodic arrangement.

Unit cell repeated in 3D’s

Have a melting point

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11
Q

Amorphous materials

A

No long range order

Non-random local structure

Have a glass transition temperature

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12
Q

What do crystal systems do

A

Reflect symmetry of arrangement of mols in the crystal

Used to identify solid forms of rugs

Most drugs are triclinic, monoclinic or orthorhombic

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13
Q

Polymorphism

A

Different crystal structures of the same compound

Diffent MP and solubility’s but the same solution/melt

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14
Q

Polymorph stability

A

At a given T and P only one form can be stable - the one with the lowest free energy (G)

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15
Q

Monotropic relationship

A

The same form is stable irrespective of temperature

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16
Q

Enantiotropic relationship

A

Either of the 2 forms may be stable depending on the temperature

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17
Q

Caffine polymorphisms forms

A

Form II changes to form I at 140dgrees

Form I then melts at 238degrees

18
Q

Polymorph stability

A

Difficult to tell wether you have a stable form or not because the metastable form may take a very long time to transform to the stable form

19
Q

Product shelf life`

A

2-3 years

Drug must remain stable over this period

20
Q

How many Polymorph does a drug have

A

Depends on how hard you look

Apsirin has 2 and paracetamol has 3 that we know of

21
Q

Crystal formation occurs in consecutive steps:

A

Supersaturation of solution -> nucleation

22
Q

Crystal growth

A

Molecules diffuse to crystal surface and attatch to the growin crystal

23
Q

Crystal habit types

A

The external shape of the crystal

Tabular
Platy
Prismatic
Acicular

24
Q

Changes in crystal habit

A

Changes in crystal growth conditions can change the habit

Increase in the degree of supersaturation tends to yeild longer needles and thinner plates

25
Q

Polymorph

A

Internal arrangement of the molecules in the crystal

26
Q

Appearance of crystals with different habits often indicates…..

A

The presence of Polymorphs but habit and polymorphism are different and may change independently

27
Q

Amorphous solid

A

Lacks long range order that is characteristic of a crystal.

Internal structure of interconnected blocks.

28
Q

Synthesis of amorphous materials

A

Rapid cooling

Fast precipitation

High energy milling

Freeze drying

29
Q

Glass transition of amorphous solid

A

At the glass transition temperature, the amorphous regions experience transition from rigid state to more flexible state making the temperature at the border of the solid state to rubbery state.

30
Q

Amorphous dissolution

A

Less stable than crystaine so easer to dissolve

Resulting solution is supersaturated

31
Q

Practical implications of amorphous

A

All amorphous systems will; recrystallise eventually

32
Q

Solvent

A

the liquid in which the material is dissolved

33
Q

Solvate

A

crystalline material that contains one or more molecule(s) of the solvent as part of the unit cell structure

34
Q

Hydrate

A

a solvate where the solvent molecule is water, i.e., water of crystallisation

35
Q

Anhydrous

A

no water of crystallisation is present

36
Q

Pseudopolymorph

A

an alternative (bad) term for solvate

37
Q

Solvate formation

A

Prepared by crystallisation from the solvent in question

Can form unexpectedly when the drug is in contact with a liquid

38
Q

Hydrate Stoichiometry

A

• Usually highly specific ratios of water to drug, which leads to monohydrate, dihydrate, trihydrate
• A particular drug can have more than one hydrate form
• Channel hydrates tend to be unstable

39
Q

Hydrate properties

A

Different MP, solubility’s and dissolution rates compared to anhydrous form

40
Q

Hydrate dissolution

A

Anhydrous = breaking up solid into molecules (endo) and interaction with solvent (exo)

Hydrate = interaction with water already taken place

41
Q

Multi component solid forms

A

Contain the drug and another molecule or ion

Salt
Solvate
Co-crystals