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Pharmaceutical Technology and Biopharmacy 2Pharmacy preparations
Product care is the insurance of the availability of the proper medicine in the right dosage form and
good quality at the time of administration. A medicine is a pharmacologically active substance
manufactured into a suitable dosage form. The dosage form consists of active compounds plus the
excipients. Excipients are part of each formulation, in order to facilitate production, improve quality
of the product, optimise performance of the product and increase patient acceptability and
compliance. The medicine is the product that is used by the patient, the functionality of the product
is determined by the process of production. This is build upon the composition and the structure of
the product. There is systemic action and local action, via systemic action the API will reach the site
of action via the blood stream, local action is the administration of the API at the side of action.
Medicine are pharmaceutical preparations and are commercially available, they are industrially
manufactured, licensed (given marketing authorisation and a registration dossier) and have
independent supervision by the government and national inspection. Extemporaneous pharmacy
preparations are prepared on demand, this happens in hospital pharmacy and community pharmacy.
These preparations are tailor-made for the patient are unlicensed and do not het a supervisor that
controls them, this results in additional responsibilities for the health care workers to assure quality
of the product. In the Netherlands the Dutch Medicines Act states that the pharmacist is allowed to
prepare a drug product for patients in its own pharmacy. The Dutch Health and Youth Care
Inspectorate are the framework for pharmacy preparations. The Royal Dutch Pharmacists Association
KNMP give guidelines for pharmacy preparations, good designs. In the Netherlands this is the dutch
pharmacist’s formulary, it gives standardised formulations and general procedures.
Pharmacy preparations means the manufacture of unlicensed pharmaceutical preparations by or at
the request of pharmacies or other healthcare establishments. Pharmacy preparations are made to
optimise pharmacotherapy for the patient. This can be essential because the commercial products
insufficiently meet specific requirements, commercial products are unavailable or tailor-made
approach is better. In order to increase patient compliance, more flexibility is allowed and better
acceptance by the patient. A preparation can vary in dose adjustment, administration route,
hypersensitivity to excipients, unavailability of a product on the market, modification of industrial
preparation, short shelf-life or investigational medicinal product. There are different types of
pharmacy preparations; it can be compounded form raw materials, so from drug substances and
excipients, it can be manipulated from licensed dosage forms this does however bring the risk of
pharmaceutical technological and biopharmaceutical problems and lastly it can be prepared prior to
use, this way the product is designed to undergo such handling. The quality of the final product is
assured by the European Pharmacopoeia in Europe and the United States Pharmacopeia in the US.
Also, there is built-in quality in the form of Good Manufacturing Practice (GMP). The guidelines of
GMP 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.
Adapted guidelines are developed to assure manufacture or production under controlled conditions
and to guarantee good product quality.
,Standardised formulations and procedures
are made by the Royal Dutch Pharmacists
Association. From the prescription to the
dispensing of medicine there is a solid
pharmacotherapeutic rationale. The first
choice is the commercially available
preparation, the second choice is the
pharmacy preparation of which the
standardised preparation have the
preference over the non-standardised
preparation. Risks are assessed to ensure the benefit for the patient and to evaluate the possible risk
related to quality level. The responsibility is for the prescriber and the pharmacist, the pharmacist is
thus co-responsible for the treatment of the patient.
Standardisation is applicable for routinely made pharmacy preparations. The design of composition
and preparation method is developed and validated in advance. Therefore each batch prepared is
prepared according to the corresponding procedures and formula and thus has the desired quality.
This quality is maintained by in-process controls and any deviations are validated. These
standardisations can be found in the FNA, there the series of procedures is described and on-line
information can be found in the KNMP Kennisbank. In the FNA, the Dutch Pharmacists Formulary, the
formulation is given, the preparation method, the storage, packaging, leaflet and background
information is provided.
Non-standardised preparations do not have a formulation readily available because this formulation
is made for a single patient or only a few patients. Before the preparation of the pharmaceutical
there is an evaluation of effectiveness, safety and quality, also a risk assessment is done. The design
and production process is drafted from scratch, there is a minimum set of quality requirements like
the composition, stability, biopharmaceutical performance but also to stick to the general procedures
as much as possible. The practical applicability, ease of use and the safety for patient and
compounder should be considered.
A product file contains all information needed on a pharmaceutical preparation, the
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 and patient information. The preparation record is the preparation
instruction for a pharmaceutical preparation. It contains all relevant information for the pharmacy
preparation and the manufacture process. This record contains all information relevant for the
pharmacy preparation and the manufacture process. The release is based on completed preparation
instructions. For accountability the document is archived.
In-process controls is made to identify critical steps in the preparation, this provides built-in quality.
An in-process control is the result of a handling, not the handling itself.
Basic operations
Key aspects in all pharmaceutical preparations are the weighing, volume measuring, dissolving and
mixing, the checking of each step, accuracy and precision and the measurement uncertainty.
Weighing determinates of the mass of an object or of a quantity of a substance. A right balance
needs to be used, a clean spatula or spoon needs to be used.
, Weighing should be done on a paper sheet, on greaseproof paper or in a vessel. Weighing is more
accurate and precise than volume measurement is because liquids are often weighed, read-out of a
weight is less subjective than volume measurement and results can be recorded. The minimum
weight is the lower limit of the balance, below which the required weighing accuracy is not adhered
to, at least this amount should be weighed on this particular balance. The rule of thumb is Mmin =
200 x d-value. To determine the exact volume of a liquid a device can be used, like graduated
pipettes, syringes or graduated measuring cylinder. Or beakers, Erlenmeyer flasks, medicine bottles
which are not fit for volume measurement.
Particle size reduction is done because in may cases requirement for particle size are set. This results
in uniformity of content, dose accuracy, equal particle size for mixing and smooth appearance of
particles. This can be done manually by grinding with a pestle in a rough stone mortar or
electronically by milling. Small particles tend to agglomerate. To mix powders, equal size of
substances is needed to prevent demixing. This is done in a metal mortar, in which is started with the
smallest quantity of the substance. It is then mixed 1:1 with another substance and this is continued
(doubling-up method). To mix fatty substances, the method of choice depends on consistency of the
substances. When substances are not too tough they can be stirred together in mortar, but when the
substances are tough, they need to be warmed in a metal mortar and then stirred with a pestle.
Dissolution is the mixing of a solid substance with a solvent, the solvent is added to the solid
substance in a beaker or Erlenmeyer, to prevent evaporation the mixing vessel is covered. To speed
up this process small particles can be used and stirring, swirling or shaking can be used. If more than
one substance needs to be dissolved it needs to be dissolved one by one, this can be assured by in-
process controls. If quantities are non-directly weighable these can be prepared in a larger batch,
reject what is not dispensed and the quantity of the API is then below Mmin. In a dilution the API is
dissolved in a suitable solvent, weigh out at least the Mmin of API. The API is dissolved in the solvent,
then the volume corresponding to the quantity API needed is taken. In a trituration powdered API is
mixed with inert excipient. Mmin of a substance is weighed and a 100-fold excipient, then mix it 1:1
and weigh out the quantity of trituration corresponding to the quantity API needed. To disperse
agglomerates use a mortar with pestle, squeeze lumps, deagglomerate, disperse in liquid or semi-
solid medium or use a rotor-stator mixer.
Oral liquid preparations
Oral dosage forms are taken in by mouth and are mostly systemically active. An oral solid dosage
form can be a tablet, capsule or power. An oral liquid can be an solution, suspension or an emulsion.
The pros and cons of oral liquids are that they can contain one or more active substances in a
suitable vehicle. It is a good alternative when the patient cannot swallow, the dose can easily be
adjusted by adjusting the volume. However, the physical, chemical and microbiological stability is
lower than that of solid dosage forms, the properties of the API are important for the choice of
pharmaceutical form, the composition can be complex and overdosing can occur easily. The target
for oral liquids are children, patients in nursing homes, patients receiving tube feeding and
determination of correct dose in a hospital setting. The dose is determined by how much at a time,
the frequency and the maximum daily dose. This is again determined by the API, Dosage form and
the patients age and condition. Other relevant things are the time when taken and contra-indications
like hypersensitivity. Dose control can be done by reviewing reliable sources, also the dose should be
adjusted by administration route and the age of a child for example, look at body weight. An oral
liquid can be a solution, suspension or an emulsion. The most commonly seen are the solutions and
suspensions. A solution has a fast absorption and the API remains in the solution or precipitates in
the stomach as small particles that rapidly dissolve. For a suspension the absorption rate depends on
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