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Summary Pharmaceutical Technolgy and Biopharmacy 2 lectures
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Pharmaceutical Technolgy and Biopharmacy 2
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PTB2Introduction
Woerdenbag
22/02/2021
Product care: to ensure availability of proper medicine, in the right dosage form, of good quality for
the patient at the time of administration. Purchasing, stock management, storage, compounding,
dispensing, patient counselling.
Pharmaceutical care: patient care + product care
Excipients = parts of formulation to facilitate, improve, optimise performance of the product or
increase patient acceptability/compliance.
Legal status of medicines
Pharmaceutical preparations
- Commercially available
- Industrially manufactured
- Licensed
- Independent supervision
Extemporaneous pharmacy preparations
- Prepared on demand
- Tailor-made for patient
- Unlicensed
- Independent supervision lacks
NL
- Dutch medicine act: geneesmiddelenwet, pharmacist is allowed to prepare a drug product
for patients in own pharmacy
- Dutch health and youth care inspectorate: inspectie voor gezondheidszorg en jeugd (IGJ),
framework for pharmacy preparations
- Royal Dutch pharmacists association KNMP: guideline for pharmacy preparations,
pharmacotherapeutically rational, good design, FNA (formularium der Nederlandse
Apothekers), standardised general procedures
Pharmacy preparations:
Ph. Eur.: ‘The ‘manufacture’ of unlicensed pharmaceutical preparations by or at the request of
pharmacies or other healthcare establishments’. The pharmacist is legally allowed to prepare and
dispense pharmaceutical dosage forms in response to a health practitioner’s prescription.
Why pharmacy preparations:
To optimise pharmacotherapy for a patient
- Commercial products insufficiently meet specific requirements
- Commercial products are unavailable
- Tailor-made approach
Increase patient compliance
- More flexibility
- Better acceptance by the patient (convenience)
When? E.g. dose adjustment, dosage form adjustments, hypersensitivity to excipients, unavailability
of product on the market, modification, short shelf-life, investigational medicinal product.
,Types of pharmacy preparations:
Compounds from raw materials
- Drug substance + excipients
Manipulated (commercially available) licensed dosage forms
- Risk of pharmaceutical technological and biopharmaceutical problems
- E.g. pulverising tablets to make capsules or conversion of oral solid dosage form into oral
liquid dosage form
Preparation prior to use
- Product designed to undergo such handling
- E.g. reconstitution of injection fluid, filling medication pump with injection from ampoule,
dissolving freeze-dried antibiotics in water to create oral solution
- VTGM = voor toediening gereedmaken
Quality assurance final product:
European pharmacopoeia (Ph. Eur.)
- Monograph pharmaceutical preparations: no essential requirements for most common
dosage forms, no monographs for individual preparations
United states pharmacopeia / national formulary (USP-NF)
- Chapter pharmacy compounding – sterile preparations
- Chapter pharmacy compounding – nonsterile preparations
- Chapter quality assurance in pharmaceutical compounding
- Monographs for compounded preparations
Built- in quality: GMP!
Quality assurance in production:
GMP for industrial production
Pharmacy preparations:
- GMP guidelines interpreted to fit in the context in which the manufacture takes place
- Several aspects of GMP are also applicable for non-industrial pharmacy preparations but full
industrial GMP is unfeasible
- Development of adapted guidelines to assure manufacture or production under controlled
conditions and to guarantee good product quality
From prescription to dispensing: solid pharmacotherapeutic rationale. 1 st choice is always a
commercially available preparation. 2nd choice is pharmacy preparation, where it can be standardised
or non-standardised. Then a risk assessment is needed, benefit for the patient vs possible risk related
to quality level. The responsibility lays for the prescriber and the pharmacist.
Decision tree:
,Standardisation is applicable for routinely made pharmacy preparations. The design of composition
and preparation method is developed and validated in advance. Each batch, prepared according to
the corresponding procedures and formula (protocol), has the desired quality: batch size,
composition, preparation method, materials and equipment. There are in-process controls, and end
controls. Any deviation should be validated.
The Dutch pharmacist’s formulary (FNA) has a series of procedures, about dosage forms, basic
operations, and processes related to medicinal products. Also online information is continuously
updated, o the KNMP kennisbank.
The FNA contains information about formulation, preparation method, storage/packaging/leaflet,
and background information (effectiveness, safety, stability).
Non-standardised preparations have no formulation readily available. It is for a single (or couple of)
patient(s). Before preparations (pharmacist’s responsibility) there should be an evaluation of
effectiveness/safety/quality, and a risk assessment. The design and production process is drafted
from scratch, resulting in a minimum set of quality requirements.
The product file should contain: pharmacotherapy, specifications of drug substance and excipients,
design of the formulation and preparation, equipment, trial preparation, test results, criteria for
release, stability, storage conditions, package/labelling/patient information.
The preparation record should contain: preparation record + preparation instruction, all information
relevant for the pharmacy preparation and the manufacture process, release based on completed
preparation instruction, and document for accountability (archived).
In-process controls: IPC (the result of handling, not a handing)
- Identify critical steps in a preparation
- Monitor and guard these steps
- Built-in quality: GMP
e.g. solid ingredient dissolved, absence of agglomerates, pH measurement.
, PTB2
Basic operations
Woerdenbag
22/02/2021
Key issues in all pharmaceutical preparations:
- Weighing
- Volume measuring
- Dissolving and mixing
- Checking of each step
- Accuracy and precision
- Measurement uncertainty
Weighing: determination of the mass of an object or a quantity of a substance
- Choose the right balance (right weighing range), use it carefully and maintain it in good
order: submit to periodical metrological control, clean/levelled/calibrated.
- Use clean spatula or spoon
- Weigh on paper sheet (solid), greaseproof paper or cellophane (semisolid), in vessel or
container (liquid)
- Weighing is more accurate and precise than volume measurement: liquids are often weighed
(especially viscous ones), read-out of a weight is less subjective than a volume measurement,
results can be recorded (electronic balance)
Categories of balances:
Minimum weight (Mmin) is the lower limit of the balance, below which the required weighing
accuracy is not adhered to. Rule of thumb: Mmin = 200 x d-value of the scale (d-value analytical
balance = 0.1 mg, d-value precision balance = 0.01 g).
Volume measurements: exact determination of a defined volume of liquid, devices
- Graduated pipettes: calibrated to dispense water, volume read out at eye level
- Syringes: practical for small volumes (< 2ml), for dilutions of parenteral administration
(ward), non-aqueous fluids
- Graduated measuring cylinders: usually volume to deliver (aqueous), read out at eye level
Beakers, Erlenmeyer flasks, medicine bottles are not fit for volume measurements.
Particle size reduction: in many cases, requirements for particle size are set. E.g. paracetamol (180)
to paracetamol (45). This for uniformity of content and dose accuracy, equal particle size for mixing,
or smooth appearance in dermal preparations. This can be done manually, by grinding with pestle in
rough stone mortar (no smaller particles than around 50 um). Or electronically by milling, also called
micronisation. Small particles tend to agglomerate more due to electrostatic forces.
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