The Science Behind X-Sprays

Numerous studies have shown that oral spray delivery systems, such as those used in X-SPRAYS™ products, serve as more effective delivery systems than pills, capsules, or even sublingual tablets.  Here are a few such studies.  Please click the title of each study to view the full documentation.

International Journal of Pharmacy & Life Sciences: Intra Oral Sprays- An Overview

Over the last three decades, intraoral dosage forms have been evolving as an acceptable and in some cases as the preferred, alternative to conventional tablets and capsules. Among them, Oral sprays are the fastest, most effective and comfortable way to take medicines, nutrients, minerals, and vitamins. They have been acquiring an important position in the market by overcoming previously encountered administration problems and contributing to the extension of patent life. Oral sprays have the unique property of rapidly releasing the drug in the oral cavity, thus obviating the requirement of water during administration. Therefore, these dosage forms have lured the market for a certain section of the patient population which includes dysphagic, bedridden, and psychic, geriatric patients. This article focuses on the transmucosal view, spray formulation aspects, advances made so far in the field of oral sprays and patented technologies.

 

A Multi-Center TrialStudies on the response of nitroglycerin oral spray compared with sublingual tablets for angina pectoris patients with dry mouth.

1997 Feb;
47(2):128-31.
Authors:  Sato, H; Koretsune, Y; Taniguchi, T; Fukui, S; Shimazu, T; Sugii, M; Matsuyama, T; Karita, M; Hori, M.
Abstract: Nitroglycerin (glyceryl trinitrate, CAS 55-63-0, NTG) administered with an oral spray may be more effective in relieving anginal pain than sublingual tablets especially when the patient’s mouth is dry. In this study, the effect of an NTG oral spray (Myocor Spray) on exercise-induced angina was compared with that of a sublingual tablet in relation to the oral dryness. In 17 patients with effort angina, graded bicycle exercise was performed twice at an interval of one week. The exercise was discontinued upon the onset of moderate anginal pain. Immediately after exercise, the oral dryness was evaluated by touching the tip of the tongue with a blotting paper for a moment. Then, 0.3 mg of NTG was administered by either a squirt of spray or a sublingual tablet in a randomized crossover fashion. Exercise results were reproducible between two exercise tests. According to the extent of the wet area of the blotting paper, the subjects were divided into two groups. In 7 patients of the wet group, the remission times of chest pain and ST segment depression were not significantly different by the formulation of NTG. In 10 patients of the dry group, however, both chest pain and ST depression more rapidly recovered with the use of the oral spray (p < 0.05 and p < 0.05, respectively). These results strongly suggest that the NTG oral spray is superior to the sublingual tablet in relieving anginal attacks when the oral wetness is decreased.

 

A Symposium: Advances in Clinical Practice of Nitrate Therapy - More rapid relief of pain with isosorbide dinitrate oral spray than with sublingual tablets in elderly patients with angina pectoris

The American Journal of Cardiology
Volume: 61 (1988)
Authors: Reisin, LH; Landau, E; Darawshi, A.
Abstract: To evaluate the possibility of improving clinical practice in the treatment of angina pectoris, the duration of relief of pain with isosorbide dinitrate (ISDN) oral spray and sublingual tablets were compared in elderly patients with chronic stable angina pectoris. Nine patients (mean age 67 years) were studied in a randomized crossover trial. The patients underwent bicycle ergometry, which resulted in typical chest pain associated with electrocardiographic ST-segment depression in all 9. The patients received ISDN oral spray or sublingual tablets immediately on termination of exercise. At least 6 hours later another ergometry test was performed and the patients were crossed over to the other drug. ISDN spray relieved pain in all patients at a mean duration of 61.6 +/- 24.4 seconds after administration, whereas the duration of relief of pain by ISDN sublingual tablets was 112.4 +/- 70 seconds. The difference was highly significant (p < 0.0005). It is concluded that clinical practice of treatment of angina pectoris in the elderly can be improved by using ISDN oral spray rather than sublingual tablets. The spray is effective at twice the rapidity of the sublingual tablet.