British Pharmacopeia

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When looking at drug facts on a medicine packaging, what is the assumption made?
Drug contains a certain amount of API e.g. 2 mg of chlorpheniramine maleate (histamine). Importance to carry out QC (consequence of neglect could lead to patient being over or under dosed). Need to protect public health with standards
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Which health care profession is the only professional group that are concerned with the nature of the drug/medicine and their use?
Pharmacists. Profession can be split into two groups: dispensing/legal regulation of medicines and clinical advice, scientists responsible for developing and formulating drug as medicines
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What are the three important aspects of medicines?
Safety (must not contain too much drug or large amounts of impurities). Efficacy (contain right drug, not too little drug, API should be in right polymorphic form, delivered according to design). Quality (fit for purpose/reproducible)
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Outline features of a controlled drug release profile (dissolution test)
Blood drug concentration against time. Rapid onset. Reaches therapeutic index (above cmax there is the minimum toxic concentration). Blood drug concentration decreases over time (irregular release profile shows abnormal patterns with no control)
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Describe features of globalisation
One of the driving forces behind the control of medicines. Large pharmaceutical companies outsource discovery/development/manufacture. Emerging pharmaceutical companies e.g. radiopharmacy. Alternative medicines (herbal). People travel more.
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What is adulteration?
Deliberate debasing by addition of other substances. Common in food and drugs/medicine. Increase profit e.g. street drugs cut with lactose, addition of lead or other weeds to herbs to increase weight/bulk, addition of colouring to create fake
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Describe features of contamination
Pollution or infection of a product (chemical/biological). Poor manufacturing equipment, storage conditions/dirty environment. Doggy raw materials
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Describe features of counterfeit
Illegal copies, worthless imitation, intent to deceive
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What is in place to protect public health?
Legally enforeable compliance with a regulatory body license e.g. EUP, BP, USP, JP, International Pharmacopeia
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To be licensed, drugs/medicines must comply with which requirements?
Safety, efficacy and quality
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What is a drug monograph concerned with?
Identity, purity, quantity and activity
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Describe features of the British Pharmacopeia (1)
Produced by the MHRA, since 1864, used in over 100 countries, incorporated all text from EUP, published annually, assists licensing/inspection from MHRA, comprehensive/addresses issues
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Describe features of the British Pharmacopeia (2)
6 volumes, drug profiles/compliance procedures, descriptions of techniques employed, information about all materials used in laboratory procedures
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Describe features of the monograph
Info about drug and excipients, must comply with all tests (require simple equipment). Definition, character, identification, use ultra pure reference standard (cost)
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Why does the monograph for aspirin have a content of 99.5-101%?
To account for standard error due to the precision of the equipment used to measure the content of aspirin
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Which tests are used for the identification of a drug?
IR, hydrolysis, colour tests, appearance, test for impurities (chemical, particulates, microbial), shelf degradation
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What are related substances?
Impurities related to the drug due to degradation/stability issues or carried over from manufacture
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What is a limits test?
Levels of impurity need to be below an acceptable level. Test amount of drug using a dissolution test and measure the absorbance. Compare results to absorbance of standard (above absorbance standard - fail, below absorbance standard - pass)
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What is an assay used for?
To see how much of the sample is in fact the drug being dealt with from the beginning. Applies to pure drug and formulated substance. Methods - weight, titrations, spectroscopy, chromatography
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What are biologics?
Very complex, do not have a simple monograph e.g insulin (do not require a biological activity assay to ensure quality
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Outline how protein drugs are tested?
Look at the molecular weight of the entity and focus on the functions of the drug instead of the structure - heterogeneity (internal/external impurities), designed sequence variation, species sequence variation, glycosylation variation
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Describe features of IR spectrophotometry
Molecules vibrate at specific frequencies depending on the strength of the chemical bond (k) and mass of the atoms (m). Simple harmonic oscillator model, stronger bond/smaller atom/higher frequency of vibration
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What are the conditions for IR spectrophotmetry?
Infrared light has the energy to excite the vibrating molecule (frequency of light matches vibrational frequency of molecule). Vibrating molecule produces a change in dipole moment such that it can interact with infrared light
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What is a dipole moment?
Dipole - imbalance of charge in a molecule. Dipole moment - charged occupied by distance. Charge dipole moment increases when distance increases (fluctuation in moleule)
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Why can you not use light alone to measure a powder?
A large refractive index difference, strong scattering, poor signal. Path length related to particle size, large particles cause total absorption of IR light/increases contribution from specular reflectance/distort spectral bands
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What can be added to help measure powder using IR light?
KBr (hygroscopic) with powder packed into small disc. Nujol mull (but oil spectral bands interfere with sample spectrum). Diamond press (infrared transparent but expensive and easy to break)
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Describe features of DRIFT
Diffused scattered ie measured by placing powder in the sample tray
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Describe features of attenuated total relection
IR light internally reflected off measuring surface of a high refractive index material, can be quantitative
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Describe features of UV-Vis
Measures excitation of pi electrons from ground state to excited state (from chromophore). 190-800 nm, used for concentration determination, solution measured in cuvettes
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What are the two key transitions for UV-Vis?
Pi to pi* and n to pi* - due to translation of charge and conjugation (n to pi* has a small extinction coefficient, longer wavelength)
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What is Beer-Lambert's Law?
A = ecl
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How do you calculate absorbance using transmission?
A = log Io/It = - logT
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How do you calculate concentration given the absorbance and specific absorbance coefficient?
c = A / A (1%, 1cm) (c in g/100 mL)
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Where are the chromophores in aspirin?
COOH, aromatic ring, COO
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Other cards in this set

Card 2

Front

Which health care profession is the only professional group that are concerned with the nature of the drug/medicine and their use?

Back

Pharmacists. Profession can be split into two groups: dispensing/legal regulation of medicines and clinical advice, scientists responsible for developing and formulating drug as medicines

Card 3

Front

What are the three important aspects of medicines?

Back

Preview of the front of card 3

Card 4

Front

Outline features of a controlled drug release profile (dissolution test)

Back

Preview of the front of card 4

Card 5

Front

Describe features of globalisation

Back

Preview of the front of card 5
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