Abstract
Dose-related adverse effects of medications are a major problem in modern medical practice. The "correct" dose, based on drug company guidelines in package inserts, may not be correct for many patients. Tablet splitting or dividing has been an accepted practice for many years as a means of obtaining the prescribed dose of medication. As model tablets for this investigation, two batches of lisinopril- hydrochlorothiazide scored tablets labeled to contain 20/12.5 mg were used. The aim of this study was to establish possible influence of tablet splitting on content uniformity of lisinopril/hydrochlorthiazide tablets. Determination of the content uniformity of lisinopril and hydrochlorthiazide in our batches, was carried out by HPLC method. The results of content uniformity studies for halves of tablets containing combination of lisinopril-hydrochlorthiazide (supposed to contain 50% of stated 20/12.5 mg in the whole tablet) were: 49.60 +/-3.29% and 49.29+/-0.60 % (lisinopril); 50.33+/-3.50% and 50.69+/-1.95% (hydrochlorthiazide) for batch I and II, respectively. We can conclude that the results obtained in this study support an option of tablet splitting, which is very important for obtaining the required dosage when a dosage form of the required strength is unavailable, and for better individualization of the therapy.
Highlights
Dose-related adverse effects of medications are a major problem in modern medical practice
Patients may be required to split tablets to (, ): ◊ obtain the required dosage when a dosage form of the required strength is unavailable ◊ provide appropriate fractional doses in a flexible dosing regimen or in a gradually increasing or decreasing dosage regimen ◊ begin therapy with the lowest possible dose to decrease the incidence of adverse effects or to gauge an individual patient’s response the process of splitting tablets cases a number of problems, some of which are patient related while others are related to the tablet or formulation
This has important ramifications as the patient may get lower than intended dose and adverse effects may be increased by degradation products
Summary
Dose-related adverse effects of medications are a major problem in modern medical practice. The ability to match doses to patients depends on the availability of multiple dose sizes and adequate dose-response information. These are not always provided, so splitting of the tablets is sometimes necessary ( ). Uneven splitting of a tablet may result in significant fluctuations in the administered dose. This may be clinically significant for drugs with a narrow therapeutic range. Removing tablets from foil packaging or exposing uncoated tablet surfaces may increase the rate of degradation of the active substance This has important ramifications as the patient may get lower than intended dose and adverse effects may be increased by degradation products. Lisinopril and hydrochlorothiazide are combined in an oral formulation for the treatment of hypertension
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