BIOAVAILABILITY OF A NEW SUSTAINED-RELEASE ANHYDROUS THEOPHYLLINE PRODUCT

The bioavailability of a new sustained-release anhydrous theophylline product (Theophylline Lavipharm(R)) was evaluated and compared with th e bioavailability of a well-established product, Theodur(R). Two group s of 12 healthy non-smokers were given single doses of 200 or 300 mg o f each product and two groups of 12 patients with asthma or chronic ob structive lung disease were given doses of 200 or 300 mg of each produ ct every 12 h for 5-day periods. The values of the area under the plas ma theophylline concentration against time curve (AUG), the maximum pl asma theophylline concentration (C-max) and the time taken to reach C- max (T-max) for the two products did not differ significantly in the h ealthy groups or in the patients. The minimum and the average plasma t heophylline concentrations and the fluctuation index were also calcula ted for the patients and there were no significant differences between the values for the two products, The; new anhydrous theophylline prod uct, Theophylline Lavipharm(R), appears to show very similar bioavaila bility to Theodur(R). No adverse reactions to the new product were rep orted.