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Summary of all the lectures of pharmaceutical technology and biopharmacy 2
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- Rijksuniversiteit Groningen (RuG)
Summary of all the lectures of pharmaceutical technology and biopharmacy 2
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Pharmaceutical technology and biopharmacy 2Lecture 1 Woerdenbag
Introduction pharmacy preparations
Pharmaceutical care consists of pharmaceutical patient care and product care.
Product care is to ensure availability of the proper medicine, in the right dosage
form, of good quality for the patient at the time of administration. For this you
take into account the purchasing, stock management, storage, compounding,
dispensing and patient counselling. Also look at the expiry date.
A medicine is a pharmacologically active substance manufactured into a suitable
dosage form. Dosage forms consist of active compounds and excipients.
The API and the dosage form determine the biopharmaceutical properties of a
compound. Biopharmaceutics is leading for the design of the dosage form and
the route of administration.
API = active pharmaceutical ingredient = drug substance
Excipients are part of each formulation. They are used to facilitate production,
improve quality of the product, optimise performance of the product and increase
patient acceptability and compliance.
A drug can induce systemic action (drug reaches the site of action via the blood
circulation) or local action (drug is administered on the site where is should
act).
Legal status of medicines:
- Pharmaceutical preparations (branded). This is the majority of the drugs
and these are commercially available, industrially manufactured and
licensed (the manufacturer has asked for marketing authorisation from
competent authorities based on safety, quality and efficacy). The
government controls everything.
- Extemporaneous preparations are prepared on demand products can be
personalised, so you get tailor-made products for the patient. Such
products are unlicensed. No government looks at the quality, however you
need to take your responsibility as a pharmacist. You have to know what to
do and why and apply certain rules.
Royal Dutch Pharmacist Association gives guidelines of how to prepare
pharmaceutical preparations. They have standardised procedures and
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,formulations (all scientifically based, in close cooperation with the field). This is
so that every pharmacist makes each preparation in exactly the same way.
Dutch Health and Youth Care Inspectorate is the framework for pharmacy
preparations.
Dutch Medicines Act pharmacist is allowed to prepare a drug product for
patients in its own pharmacy.
A pharmacist should be able to prepare medicines. The pharmacist needs
education, training and practice. If you do not practice you are not competent
(deskundig) according to the law.
Why pharmacy preparations?
- To optimise pharmacotherapy for a patient, when commercial products are
unavailable or do not meet the requirements tailor-made approach.
- To increase patient compliance, so that there is more flexibility and better
acceptance by the patient.
When pharmacy preparations?
- Dose adjustment drugs are made for adults, so for children the dose
must be adjusted.
- Dosage form adjustment (other route of administration) when there are
for example swallowing problems.
- Hypersensitivity to excipients for example to preservatives. This causes
a change of the shelf-life but the patients are able to take the drug.
- Modification of industrial preparation tricky.
- Short shelf-life radioactive labelled preparations need to be given on the
same day as they are prepared.
- Investigational medicinal product.
- Unavailability of a product on the market.
Types of pharmacy preparations:
- Compounded from raw materials mix the drug substances with
excipients.
- Manipulated commercially available licenced dosage forms changing the
dosage from tablet to liquid when there are swallowing problems. There is
a risk on pharmaceutical technological and biopharmaceutical problems.
- Preparation prior to use products designed to undergo such handling.
VTGM = voor toediening gereedmaken. You need to adjust the preparation
before administering.
Quality assurance of the final products:
- European pharmacopoeia essential requirements for most common
dosage forms. There are no monographs for individual preparations.
- Built-in-quality (GMP) guidelines interpreted to fit in the context in which
the manufacture takes place. The GMP is there to assure that production
happens under controlled conditions and to guarantee good product
quality.
From prescription to dispensing:
- Solid pharmacotherapeutic rationale
- 1st choice: give the patient a commercially available preparation. This
quality is the highest because it is produced according to the GMP.
- 2nd choice: pharmacy preparations: preferably standardised. Otherwise
non-standardised, but then there is a quality risk. You need to balance out
the benefit for the patient and the possible risk related to the quality level.
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, You are responsible as the prescriber and pharmacist. Non-standardised
preparations are designed and produced from scratch no protocols.
Standardisation is applicable for
routinely made pharmacy
preparations. The composition and preparation method are developed and
validated in advance. Each batch that is prepared according to the corresponding
procedure and protocol has the desired quality. Each time, the same batch size,
composition, preparation method and materials and equipment are used. Any
deviation from the procedure should be validated.
The Dutch Pharmacist’s Formulary (FNA) contains information on all kinds of
standardised preparations including storage, packaging and background
information. Also everything online on KNMP Kennisbank.
A product file contains a lot of information about the preparation: specifications
of the 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.
Batch preparation record: you make a preparation instruction for each single
batch. You write down each amount you weighed out etc. This is supported by a
product file. These products are archived to be able to look back if something
went wrong.
In-process control is important to show built-in quality. You have to monitor and
guard each step and identify critical steps in a preparation. For example when
you dissolve a solid in a liquid you have to be sure that it has dissolved
completely.
Lecture 2 Woerdenbag
Basic operations
Key issues in all pharmaceutical preparations: weighing, volume measuring,
dissolving and mixing. Each step should be checked. Everything should be
accurate and precise.
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, Weighing is the determination of the mass of an object or of a quantity of a
substance. You should use a balance with the right weighing range and the
balance should be clean, levelled and calibrated.
Weighing is more accurate and precise than a volume measurement, because the
read-out of a weight is less subjective than a volume measurement. Results can
be recorded with an electronic balance.
The minimum weight (Mmin) is the lower limit of the balance. Below this weight,
the required weighing accuracy is not reached. At least this amount should be
weighed on this particular balance.
Rule of thumb: Mmin is 200 times the d-value (10 x readability). So for an
analytical balance d = 0.1 mg Mmin = 20 mg.
Volume measurement is the exact determination of a defined volume of a
liquid. This can be by using graduated pipetted, syringes and graduated
measuring cylinders. Beakers, Erlenmeyer flasks and medicine bottles are not fit
for volume measurements.
Particle size reduction: The particle size is important for the uniformity of
content and dose accuracy. For mixing, you want the compound to have equal
particles. If you want to formulate a powder into a dermal preparation you should
have very small particles to get a smooth appearance.
1. Grinding with a pestle in a rough stone mortar reduce the particle size
to 50 micrometres.
2. Milling (electronically) micronisation.
Small particles tend to agglomerate by electrostatic forces.
Mixing powders: you want an equal particle size of the substances to prevent
demixing. You start with the smallest quantity and mix 1:1 with another
substance. Then continue mixing 1:1.
If you have to mix fatty substances this can be tough, especially when it is cold.
Put it on a warm water bath reduced viscosity easy mixing. When the fatty
substance is not too tough, you can stir it together in a mortar.
Dissolution of a solid with a solvent: add the solvent to the solid substance.
If you do it the other way around the powder will climb up on the rim of your
glass and will not dissolve. Dissolution can be done in a beaker or Erlenmeyer
flask. To speed up the process you should use small particles and stir, swirl,
shake, or heat it. When you have to dissolve multiple substances, you should to
this 1 by 1.
Non-directly weighable quantities: when the quantity of API or excipient is
below Mmin. You could produce a larger batch. But this is not done because you do
not want to dispense it (economically unattractive). You could make a dilution
(liquid) or a trituration (solid).
- Dilution: API is dissolved in a suitable solvent. Weigh out at least the M min
of the API. Dissolve the API in the solvent. Then take the volume
corresponding to the quantity of the API that you need.
- Trituration: powdered API is mixed with an inert excipient, which does not
react with the API and has no pharmacological effect. You weigh out at
least the Mmin of the substance and then a (10- or) 100-fold of the
excipient. Mix this 1:1. Then weigh out the quantity of the trituration
corresponding to the quantity of API needed.
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