Abstract: The invention relates to developing a novel water and capsule formulation using fenofibrate which is difficult to dissolve and control its release rate in vitro. For example, the invention relates to the creation of capsules and wafers comprising: fenofibrate, a surfactant, a carrier wax, a film former, a plasticizer, and optionally a super disintegrant or other ingredients. The invention further relates to the process of forming such capsules and wafers.

Abstract: The invention relates to a pharmaceutical composition in the form of a system in film form for transmucosal administration of steroid hormones. An administration system for steroid hormones which dissolves in the mouth and which releases with a high bioavailability is disclosed. The administration system in film form dissolves in the mouth preferably in a period of less than 30 min, and the steroid hormone entering the bloodstream transmucosally from the administration system leads to a rapid rise in the concentration in the blood. It is thus possible to achieve a maximum concentration of this steroid hormone in the blood in a period of less than 60 min after administration.

Abstract: The invention relates to a pharmaceutical composition in the form of a system in film form for transmucosal administration of steroid hormones. An administration system for steroid hormones which dissolves in the mouth and which releases with a high bioavailability is disclosed. The administration system in film form dissolves in the mouth preferably in a period of less than 30 min, and the steroid hormone entering the bloodstream transmucosally from the administration system leads to a rapid rise in the concentration in the blood. It is thus possible to achieve a maximum concentration of this steroid hormone in the blood in a period of less than 60 min after administration.

Abstract: An edible oral film strip dosage form containing an unpalatable basic active pharmaceutical ingredient and an ion exchange resin as a primary taste masking agent, along with an optional acidic agent and further optionally containing one or more secondary taste masking agents is provided. The edible oral film strip dosage matrix is formed from at least one water soluble or miscible polymer(s). The optional secondary taste masking ingredients include one or more of flavoring agent(s), sweetener(s), cooling sensation agent(s), and taste receptor blocker(s). Methods for preparing the inventive edible oral film strip dosage forms are disclosed, as well as their method of administration.

Abstract: A childproof packaging for individual doses, in particular for preparations for administration in film form, wherein the packaging constitutes a bag produced by sealing, which has a covering layer which is provided at each side of the packaging with local weak points which do not touch the edge of the packaging, wherein the local weak points form a cohesive pattern which runs around the individual dose in an arc or a curve and overlaps an angular region of at least 90° when considered from the main area of the individual zone. The local weak points have a start area and an end area which have a Y configuration when the local weak points on each side of the packaging are superposed.

Abstract: A method for producing a tightly sealed bag packaging and to a tightly sealed bag packaging having at least one perforation and a receiving area surrounded by a plate-shaped edge region for the inert packaging of a product containing active ingredients, wherein the bag packaging comprises cover films or cover film segments bounding the receiving area and forming the edge region. The cover films or cover film segments are each provided with a channel system having at least one channel. The channel system crosses the part of the cover film or the cover film segment covering the receiving area. At one end, each channel is provided with a branching into two channel branches, Furthermore, a slit is arranged between the two channel branches, interrupting a peripheral edge of the bag packaging.

Abstract: A method for producing childproof, highly inert individual dose packagings for transdermal therapeutic systems or film-like forms of administration in the form of a sealing edge bag that can be peeled back with a complete surrounding and continuous sealing surface, comprising two packaging elements, that are arranged on top of each other and form the upper side and the bottom side of a bag containing the product, wherein at least one layer of the packaging material elements is a metal layer and at least one packaging material element a film laminate with at least three-layer design; and the outer layer of the at least three-layer film laminate comprises at least one line-shaped weakening that is not touching the edge of the packaging on the upper and bottom side and the line-shaped weakening has a reduced resistance to tear for opening the packaging.

Abstract: An edible oral film strip dosage form containing an unpalatable acidic active pharmaceutical ingredient, particularly ketoprofen, and an ion exchange resin as a primary taste masking agent, along with an optional alkaline agent and further optionally containing one or more secondary taste masking agents is provided. The edible oral film strip dosage matrix is formed from at least one water soluble or miscible polymer(s). The optional secondary taste masking ingredients include one or more of flavoring agent(s), sweetener(s), cooling sensation agent(s), and taste receptor blocker(s). The inventive dosages minimize or completely mask the bitterness, burning sensation and throat irritation associated with many acidic active pharmaceutical ingredients. Methods for preparing the inventive edible oral film strip dosage forms are disclosed, as well as their method of administration.

Abstract: A method for producing a tightly sealed bag packaging and to a tightly sealed bag packaging having at least one perforation and a receiving area surrounded by a plate-shaped edge region for the inert packaging of a product containing active ingredients, wherein the bag packaging comprises cover films or cover film segments bounding the receiving area and forming the edge region. The cover films or cover film segments are each provided with a channel system having at least one channel. The channel system crosses the part of the cover film or the cover film segment covering the receiving area. At one end, each channel is provided with a branching into two channel branches, Furthermore, a slit is arranged between the two channel branches, interrupting a peripheral edge of the bag packaging.

Abstract: A childproof packaging for individual doses, in particular for preparations for administration in film form, wherein the packaging constitutes a bag produced by sealing, which has a covering layer which is provided at each side of the packaging with local weak points which do not touch the edge of the packaging, wherein the local weak points form a cohesive pattern which runs around the individual dose in an arc or a curve and overlaps an angular region of at least 90° when considered from the main area of the individual zone. The local weak points have a start area and an end area which have a Y configuration when the local weak points on each side of the packaging are superposed.

Abstract: A childproof packaging for individual doses, in particular for preparations for administration in film form, wherein the packaging constitutes a bag produced by sealing, which has at least one each side a covering layer which is provided at least on one side with local weak points which do not touch the edge of the packaging, wherein the local weak points form a cohesive pattern which runs around the individual dos in an arc or a curve and overlaps an angular region of at least 90° when considered from the main area of the individual zone.

Abstract: A childproof packaging for individual doses, in particular for preparations for administration in film form, wherein the packaging constitutes a bag produced by sealing, which has at least one each side a covering layer which is provided at least on one side with local weak points which do not touch the edge of the packaging, wherein the local weak points form a cohesive pattern which runs around the individual dos in an arc or a curve and overlaps an angular region of at least 90° when considered from the main area of the individual zone.

Abstract: A polymer-based preparation in film form for biphasic release of substances present therein to liquid surroundings, is characterized in that the preparation comprises at least two polymer matrix layers which differ in terms of their construction from polymers, with release taking place rapidly from one of the layers, and release taking place slowly from at least one other layer.

Abstract: A packaging for active substance-containing films. The packaging comprises a carrier layer and a covering layer connected releasably to the latter, has in a paired arrangement two opposite surface regions which are separated from one another by a web and within which the covering layer is not connected to the carrier layer. Two spaces are formed, separate from one another and enclosed on all sides, for receiving the films in pairs. Within the web, a further surface region is present, in which the carrier layer is not connected to the covering layer, with the result that a cavity enclosed on all sides is formed. At least one perforation line is present within the web.

Abstract: A process for treating a patient by medicinal therapy by a film-shaped therapeutic system. The process comprises the steps of applying a film-shaped therapeutic system comprising at least three layers connected with each other onto the oral mucosa of a patient in need of medicinal therapy for a period of up to 24 hours and releasing the active substance with an initial burst dose and a subsequent maintenance dose. The film-shaped therapeutic system comprises at least three layers connected with each other for transmucosal administration of active substances. The system has a layer which is mucoadhesive in an aqueous environment and a backing layer which is at least two-layered. At least one of these layers contains an active substance. The mucoadhesive layer is capable of swelling in an aqueous media, but is insoluble or only poorly soluble in an aqueous media.

Abstract: A method for producing childproof, highly inert individual dose packagings for transdermal therapeutic systems or film-like forms of administration in the form of a sealing edge bag that can be peeled back with a complete surrounding and continuous sealing surface, comprising two packaging elements, that are arranged on top of each other and form the upper side and the bottom side of a bag containing the product, wherein at least one layer of the packaging material elements is a metal layer and at least one packaging material element a film laminate with at least three-layer design; and the outer layer of the at least three-layer film laminate comprises at least one line-shaped weakening that is not touching the edge of the packaging on the upper and bottom side and the line-shaped weakening has a reduced resistance to tear for opening the packaging.

Abstract: A polymer-based preparation in film form for biphasic release of substances present therein to liquid surroundings, is characterized in that the preparation comprises at least two polymer matrix layers which differ in terms of their construction from polymers, with release taking place rapidly from one of the layers, and release taking place slowly from at least one other layer.

Abstract: Childproof, highly inert individual dose packagings (1) for transdermal therapeutic systems or film-like forms of administration in the form of a sealing edge bag that can be peeled back with a complete surrounding and continuous sealing surface, comprising two packaging elements, that are arranged on top of each other and form the upper side and the bottom side of a bag containing the product, wherein at least one layer of the packaging material elements is a metal layer and at least one packaging material element a film laminate with at least three-layer design; and the outer layer of the at least three-layer film laminate has a minimum tear resistance of 30 N, wherein said outer layer comprises at least one line-shaped weakening that is not touching the edge of the packaging on the upper and bottom side and the line-shaped weakening has a reduced resistance to tear for opening the packaging. The invention further relates to a method of production thereof.

Abstract: A polymer-based preparation in film form for biphasic release of substances present therein to liquid surroundings, is characterized in that the preparation comprises at least two polymer matrix layers which differ in terms of their construction from polymers, with release taking place rapidly from one of the layers, and release taking place slowly from at least one other layer.

Abstract: The invention relates to a packaging unit comprising a container and hygroscopic or humidity softenable film-like materials. For this purpose, said film-like materials are stacked in the container and a separating material which is chemically inert and physically stable with respect thereto is arranged at time between said film-like materials. Each time, said separating material is brought into contact with two film-like materials and does not adheres or adheres less strongly to at least one film-like material that to the other film-like material. Said invention makes it possible to develop a packaging unit provided with a container which guarantees a reliable individual withdrawal of the hygroscopic film-like materials.