Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Patent
1992-02-12
1995-08-01
Page, Thurman K.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
424435, 424468, 424469, 424484, 424488, 514781, A61K 926
Patent
active
054378729
DESCRIPTION:
BRIEF SUMMARY
DESCRIPTION
The present invention relates to improved pharmaceutical compositions. In particular, the present invention relates to pharmaceutical compositions in tablet form, formulated to provide a controlled and sustained release of a pharmaceutically active ingredient over an extended period of time. The invention also relates to pharmaceutical compositions in the form of buccal tablets or sub-lingual lozenges and to a device for retaining a sustained release or buccal tablet in place in a patient's mouth.
It has been recognised, for more than 10 years, that patients in intensive care units, particularly those who require artifical ventilation, are extremely susceptible to bacterial infection. In many cases, despite good nursing care, patients die from bacterial infection rather than from an original traumatic injury. Gram-negative bacteria are responsible for most of these potentially pathogenic infections. Once a patient has been admitted to hospital, his endogenous aerobic flora are replaced by nosocomial (hospital originating) gram-negative bacteria, such as Pseudomonas, Acinetobacter and, Klebsiella, which may rapidly colonise the oropharynx, stomach and. intenstines. Once the digestive tract has been so colonised, subsequent colonisation and infection of major organ systems may occur.
More than 80% of critically ill patients are colonised by nosocomial gram-negative bacteria within 10 days of admission to hospital (Northey et al. (1974), Surgery, Gynaecology, and Obstetrics 139, 321-5: Sheild, Hammill and Neale (1979), Intensive Care Medicine 5, 171-81 and; Thorpe, Richards and Telfer (1979) Anaesthesia 34, 643-50) and these organisms are responsible for the majority of late infections (Rose & Babcok (1975) American Journal of Epidemiology 101, 495-501 and; Weinstein and Kabins (1981) American Journal of Medicine 70, 449-54). Considerable success has been achieved in reducing the incidence of such infection by the prophylactic administration of non-absorbable antibiotics to selectively decontaminate the digestive tract. The antibiotics are selected to the potentially pathogenic aerobic gram-negative micro-organisms from the digestive tract, leaving the mainly endogenous anaerobic flora substantially unaffected. This work was carried out by C. P. Stoutenbeek and H. K. F. Van Saene and co-workers since 1982 and has been reported in: Journal of Antimicrobial Chemotherapy (1984) 14, supplement B, 203-211; Journal of Antimicrobial Chemotherapy (1987) 19 , 513-520 and; Intensive Care Medicine (1986) 12 , 419-423. The non-absorbable antibiotics were administered through a nasogastric tube, in the form of an extemporaneously prepared suspension of Polymyxin E (15%), Tobramycin (12%) and, amphotericin (73%), and applied to the buccal mucosa in the form of a commercially available paste (ORABASE Registered Trade Mark, available from Squibb) containing 2% polymyxin E, 2% tobramycin and 2% amphotericin B. Both preparations were administered to patients every four hours, with gastric suction being applied for the first hour after administration. To prevent infections of the respiratory tract, systemic antibiotic prophylaxis may also be given to multiple trauma patients.
Although prophylactic and selective decontamination of the digestive tract has proven to be very successful, it is difficult and time consuming in application. These difficulties have prevented the method from becoming more widely used.
According to a first aspect of the present invention there is provided a pharmaceutical tablet or lozenge, comprising a non-absorbable pharmaceutically active agent in combination with a tablet matrix arranged for providing controlled and sustained release of said agent into the mouth and gastro-intestinal tract, from a buccal or sub-lingual location. The term non-absorbable, when used herein to describe a pharmaceutically active agent, defines such an agent that is not absorbed into the blood, or bodily fluids in any substantial quantity from a normal and untraumatised human digestive tract.
Preferably, the ta
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Page Thurman K.
Spear James M.
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