an article of Josep Arasa Lopez
CEO of – Specialist in industrial and galenic pharmacy
As is known, there are several routes to be able to administer the pharmaceutical specialties and depending on the route of administration, the active principles are formulated in a different galenic form.
The oral route is generally the most common for the administration of drugs and the oral solid pharmaceutical forms are the most used presentations. Some patients, especially nonagenarians, present difficulty swallowing and there are many patients and caregivers who, to obtain a desired dose, divide the solid pharmaceutical forms, and other times, to facilitate swallowing, they simply crush them. And when the presentation is in the form of capsules, they proceed to open them and manage their content.
Thus, we ask ourselves… is it correct to divide or crush the tablets? Can the capsules be opened?
The Laboratories of Pharmaceutical Specialties manufacture drugs for ease of administration, optimal bioavailability, and maximum therapeutic efficacy. The decision to cut or crush a tablet or open a capsule should not be taken lightly.
On what criteria are the Pharmaceutical Laboratories based for the choice of a pharmaceutical form? When determining the presentation of a pharmaceutical specialty, Pharmaceutical Laboratories are based on different criteria and conditions to determine the dosage form, such as:
– According to the Dosage. Dose to administer…
– Pharmacological. Bioavailability…
– Mechanism and action of the drug. Pharmacokinetics…
– Organoleptic. Colour, flavour, galenic form…
– Physicochemicals. Interactions, incompatibilities, stability…
What risks are assumed when modifying a pharmaceutical form?
– Responsibility. When modifying a pharmaceutical form, the responsibility for any adverse effect may be transferred to the person responsible for handling it.
– Dosage error.
– Possibility of increasing side effects.
– Loss of effectiveness.
– Increased toxic potential.
At SDM we have taken into account different criteria to develop the list of drugs that cannot be crushedbut a general rule must always be respected:
Fractionate
The presence of a score does not indicate that the tablet can be divided and in the case that it can be divided, it is recommended to use a splitter.
Crush
As a general rule, we must refrain from crushing or opening the capsules of the following presentations:
• Delayed, coated, modified or prolonged release, sublingual, orodispersible and gastro-resistant pharmaceutical forms
• If the active principle is unstable
• Effervescent or tablet forms
• With narrow therapeutic margin
• Cytostatic and immunosuppressive
• When it contains irritating substances
• When its administration indication is sucking or chewing
• When it contains liquid form. Soft capsules.
What are the advantages of administering crushed medication?
– Administration of medication to patients with intentional non-adherence
Patients who present intentional non-adherence when administering the medication in crushed form, which can be dispersed or diluted in liquids (water or juice) or semi-solids (jam, compote, yogurt, etc.) and thus we can control that medication is ingested.
– Patients with difficulty swallowing
This system allows these patients to ingest the medication more easily.
At SDM, to prepare the list of medicines that cannot be cut, crushed or open the capsules, we have consulted the manufacturer’s recommendations and we have always respected their criteria. In our study we have found different authors who do accept the grinding of some drugs, against the manufacturer’s criteria. From SDM, the manufacturer’s recommendations have always prevailed.
The table on medicines that cannot be divided or crushed and the capsules that cannot be opened is structured as follows: it has been prepared in alphabetical order of the active ingredients. Then the trademark appears in some. The second column contains the Galenic form in abbreviated form. The third column is the presentations. The next three specify whether cutting, shredding, or opening is not recommended. The next column lists the alternatives and the last one the observations.
All interested persons can consult this guide to drugs that cannot be divided or crushed .