Food or edible material: processes – compositions – and products – Processes – Preparation of product which is dry in final form
Patent
1994-11-23
1997-06-03
Kishore, Gollamudi S.
Food or edible material: processes, compositions, and products
Processes
Preparation of product which is dry in final form
424489, 264 41, 4284022, A61K 9127, A61K 916
Patent
active
056352050
DESCRIPTION:
BRIEF SUMMARY
FIELD OF INVENTION
The present invention relates to a lipid carrier system for a local anaesthetic comprising a defined lipid system which includes at least two lipid components, wherein at least one of the lipid components is polar and amphiphatic and one is nonpolar. The system may further include a hydrophilic solvent and additives or matrices for adapting the system for administration to mucous membranes and for transdermal administration.
DESCRIPTION OF THE INVENTION
According to the invention the lipid carrier system, referred to as Biosome Forming Matrix (BFM), is characterized by a defined system of at least two defined lipid components chosen from classes of different polarity, of which at least one of the lipid components is brayer forming. By this is meant that discrete lipid particles, referred to as Biosomes, are formed spontaneously when the system interacts with excess aqueous media. This lipid system is also described in the International Patent Application WO 92/05771. By a defined lipid component is meant a lipid whose chemical composition is known and controlled. This will be explained in more detail below.
As before mentioned, at least one of the lipid components of the system is polar and amphiphatic and one is nonpolar. The amphiphatic and polar component is preferably phosphatidylcholine and the nonpolar is preferably chosen from the classes of mono-, di- and triglycerides or a mixture thereof.
The amount of the polar lipid class components will preferably be present in an amount that corresponds to 0.5-90 % (w/w) of the lipid system, preferably corresponding to the range of 5-50 % (w/w).
The property `bilayer forming` is a well-known physical parameter and can be established readily with suitable physicochemical methods (e.g. surface balance method). The establishment of the formed discrete lipid particles can be done by physical and/or chemical methods, such as microscopy using polarized light, or diffraction methods.
The variation in the lipid composition provides the control mechanism by means of which Biosomes are formed and thereby also the rate at which Biosomes are formed which, will serve as a controlling factor for either immediate or sustained release of the entrapped or associated bioactive materials.
The lipid system according to the present invention can only be defined in the general terms set forth in claim 1. The difference between the matrix according to the invention and lipid systems that are already known to art resides in the ability of spontaneously forming Biosomes in contact with excess aqueous media. Thus, the inventive lipid system can be obtained by a) using well defined lipid components from at least two different lipid classes and by b) designing these lipid components into unique lipid matrices, which form Biosomes in vivo when interacting with water.
The following definitions are used in this document: acyl carriers, such as glycerol, sphingosine, cholesterol, and others or derivatives thereof, to which one or more fatty adds are or can be linked. Similar molecules that contains a substantial hydrocarbon portion may also be included.
The lipids used for the Biosome Forming Matrices (BFMs) can be grouped in different lipid classes, depending on their polarity, namely: nonpolar constituents are hydrocarbons, or non-swelling amphiphiles, such as mono-, di- and triacylglycerols, cholesterol, fatty alcohols or cholesterol esters. activity, such as phospholipids or glycolipids. Depending on their specific interactions with water, they are subdivided further into the categories of swelling and soluble amphiphiles. glycolipids, being surface active. (phosphatidylcholine), sphingomyelin, PI (phosphatidylinositol), with a molecular geometry that preferentially leads to bilayer structures in the presence of water.
The lipids used for the BFM consist of a mixture of lipid classes that are characterized by their different polarities. Polar lipids, such as phospholipids or glycolipids, and nonpolar lipids, such as mono-, di- and triglycerides, are the main const
REFERENCES:
patent: 5004611 (1991-04-01), Leigh
patent: 5059421 (1991-10-01), Loughrey
Abstract--Stozek, et al., Pharmazie 44, pp. 466-468, 1989.
Nyqvist H.ang.kan
Ragnarsson Gert
Tingvall Per
Kishore Gollamudi S.
Pharmacia & UpJohn AB
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