Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Cosmetic – antiperspirant – dentifrice
Reexamination Certificate
1999-12-17
2002-10-08
Dees, Jose′ G. (Department: 1616)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Cosmetic, antiperspirant, dentifrice
Reexamination Certificate
active
06461624
ABSTRACT:
The present invention relates to a protective composition for skin which protects against bacterial, viral and fungal infection In particular, the invention relates to anti-infective (infection preventing) products, to be used to control infections caused by gram positive organisms such as Methicillin Resistant
Staphylococcus aureus
(MRSA), Pneumococci and Vancomycin Resistant Enterococci (VRE) as well as gram negative bacteria such as
Escherichia coli
and
Pseudomonas aeruginosa.
The invention provides a durable handcream which is retained on the hands despite use of the hands. More particularly the invention relates to a protective handcream of the type known as a “barrier” handcream. The invention also provides body lotions, liquid soaps, shampoos, soap bars and creams generally, which are protective.
BACKGROUND OF THE INVENTION
Although medical science is continually advancing with new techniques and drugs being developed almost daily, cross-infection in hospitals is still a common occurrence with major implications. Micro-organisms may be acquired and transmitted by one of the following routes: direct contact, airborne or via fomites. Although these routes are well understood and procedures to control them are standard practice, pathogenic organisms still exist in the hospital environment.
The spread of infection by direct contact is considered to be the most important method of transmission both for gram positive and gram negative organisms, and it is agreed that the hands of hospital personnel play an important role in the transmission of infection.
Many different organisms exist on the skin. Some belong to the normal flora of the skin and are harmless commensals, which may however, on occasion, become opportunist pathogens in patients who are unusually susceptible to infection such as those in intensive care units. Organisms on the skin can be classified into three categories:
Transient organisms—micro-organisms which are deposited on the skin but do not multiply there,
Temporary residents—contaminants which multiply on the skin and persist for short periods;
Resident organisms—permanent inhabitants of the skin which colonise the deeper crevices of the skin and hair follicles.
Removal or killing of the transient flora is generally considered sufficient to prevent the transfer of cross-infection in hospital, but removal of the resident flora is an additional advantage which should be achieved if possible.
Skin disturbances lead to difficulties in the process of skin cleansing Patients with eczema are often colonised by
Staphylococcus aureus
to a greater extent than even those suffering from the strongly scaling disease psoriasis. Patients with an atopic eczema are also more frequently colonised because their skin is not as smooth as those with completely healthy skin. Extensive and frequent use of antiseptic-detergent preparations, such as those used in hospitals, causes moderate to severe drying of the skin of the hands, and indeed small wounds on the fingertips in some cases. Low relative humidity during winter results in additional stress to the skin. More than half the nurses involved in one clinical study had increased numbers of bacteria on their hands after only one week's use of an antiseptic detergent preparation (Ojajarvi, J. 1978). The increase was thought to be due to the drying and skin damaging effects of frequent hand washing between every patient contact, but the age of the personnel and nature of duties undertaken were also contributory factors.
Currently a source of major concern is the appearance of resistant strains of bacteria which survive the cleansing processes, and which have become resistant to antiseptics, antibacterials and antibiotics which originally destroyed them. No amount of hand washing is capable of removing these micro-organisms. Of particular importance amongst the gram positives are resistant strains of
Staphylococcus aureus
(Methicillin Resistant
Staph. aureus
—MRSA), resistant Pneumococci and Enterococci (Vancomycin Resistant Enterococci—VRE).
There is an ever increasing awareness of the need to reduce cross infections in hospitals This awareness has increased with the appearance of these resistant strains The spread of these infections now has enormous consequences for patient care with patients during, hospital stay increasing, and hospital budgets soaring. Drugs used to fight MRSA are now responsible for up to 10% of the drug bill at some U.S. hospitals.
Guidelines prepared by Health Departments around the world recommend, in the absence of anything better, that hand washing is the most important factor currently available in preventing the spread of MRSA and other pathogenic bacteria. These guidelines recommend washing the hands with an antiseptic detergent (e.g. Chlorhexidine-containing hand washes), before and after each patient contact.
The research of Ojajarvi (1978) referred to above shows the limitations of these recommendations. Furthermore, the work of Aly and Maibach (1979) proved that chlorhexidine significantly reduced the normal flora of the hands. These synthetic antiseptic containing preparations suppress the protective gram positive population (Aly & Maibach, 1976), resulting in a potentially harmful shift towards gram negative colonisation. Long-term and frequent use of detergents containing synthetic bacteriostatic agents may lead to detrimental overgrowth of a particular bacterial species which would otherwise have been unable to survive on normal healthy skin.
In addition, allergic contact dermatitis caused by chlorhexidine gluconate and diacetate has been reported by Reynolds et al. (1990) and Knudsen et al.(1991). By far the most alarming problem was the incidence of a hospital outbreak of Chlorhexidine-resistant
Proteus mirabilis
resulting in an outbreak of urinary-tract infections affecting 90 patients in Southampton between July 1980 and May 1985 (Dance et al. 1987).
These results show that handwashing alone can not prevent the spread of infections.
Boddie et al 1992, J. Dairy Sci. 75 1725-1730 discusses the use of post-milking teat germicides containing Lauricidin (Registered Trade Mark for glycerol monolaurate), saturated fatty acids, lactic acids and lauric acid. Various compositions were determined against new IMI (intra-mammary infection) caused by
Staphylococcus aureus
and
Streptococcus agalactiae
in three controlled infection trials.
Each of the compositions contained Lauricidin (TM) and lactic acid. Two of the compositions further contained lauric acid.
Kabara (1983) “Medium Chain Fatty Acids and Esters” discusses the history of various types of soaps, and further discusses the suitability of various fatty acids as food additives. It is stated therein that it is well established that unsaturated fatty acids exhibit an antibacterial influence on gram-positive micro-organisms. The inhibitory effects of unsaturated fatty acids are stated to increase as the number of double bonds in the molecule increase.
International Application PCT/US95/02588 (Publication No. WO 95/26710) discusses a personal skin moisturising and cleansing bar composition which comprises both a skin cleansing agent and a lipid moisturising agent in the same bar, which deposits an effective amount of the lipid on the skin of the user in a bath or shower. The bar composition contained both Na lauric soap and lauric acid. The bar thus cleanses and leaves a moisturising lipid layer on the skin. It is not said to have any anti-microbial properties and does not take the form of a leave-on cream or lotion.
U.K. Patent Application No. 675,152 discloses oleaginous cosmetic cleansing creams which are used to loosen and dissolve dirt from the skin and which are easily removed from the skin using water alone. Use in these compositions of monoesters of substantially saturated fatty acids of about 12 to 18 carbon atoms with saturated aliphatic polyhydric alcohols of 2 to 3 carbon atoms is disclosed. The composition of Examples 2 to 7 discloses the use of a para hydroxy benzoic acid as a preservative. It is expressly sta
Clair James
Eggers Sabine
Van Der Meer Michael John
LandOfFree
Skin-protective composition does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Skin-protective composition, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Skin-protective composition will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2988989