Lts Lohmann Therapie-systeme Ag

Novartis Ag

Santhera Pharmaceuticals (schweitz) Ag

Santhera Pharmaceuticals Ag

Markus Krumme

Christian Von Falkenhausen

Karin Ludwig

Michael Li

Bodo Asmussen

Keith Jensen

Wolfgang Laux

Frank Seibertz

Tina Rademacher

Grace A Behrend

Judith Dubach-Powell

Rudolf Hausmann

Petra Brandt

Stephen J Dodd

Michael Dittgen

David Hook

Walter Mueller

Dale W Ploeger

Gordon Stout

Sascha General

Massimo Moratto

Joerg Ogorka

Michael Simon

Norbert Rasenack

Michael Hsin Chwen Li

Steffen Lang

Patrick Tritschler

Stefan Steigmiller

Hendrik Schneider

Albert Radlmaier

Despina Solomonidou

Joerg Kreuter

Christian Gutsche

Elodia Di Renzo

Jim Parks

Fabian Weber

Frank Seiberts

Steven Dodd

A method of preparing a pharmaceutical product comprises the steps of (a) providing a neat active pharmaceutical ingredient (API) complying with at least five of the following parameters determined by using a FT4 powder rheometer: (i) specific basic flow energy of at most 60 mJ/g; (ii) stability index of 0.75 to 1.25; (iii) specific energy of at most 10 mJ/g; (iv) major principle stress at 15 kPa of at most 40; (v) flow function at 15 kPa of at least 1.3; (vi) consolidated bulk density at 15 kPa of at least 0.26 g/mL; (vii) compressibility of at most 47%; and (viii) wall friction angle of at most 40&#xb0;; (b) dispensing the neat API of step (a) into a bottom part of a pharmaceutical carrier using a vacuum assisted metering and filling device; and (c) encapsulating the bottom part, thereby producing a pharmaceutical product.

Method for preparing a pharmaceutical product

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.

Wafer and capsule formulations with enhanced dissolution rates for fenofibrate

A single-dose package for transdermal therapeutic systems or film-shaped administration forms, in the form of a tear-open sealed-edge pouch with a completely surrounding and continuous non-peelable sealing surface. The single-dose packages are provided with two packaging material elements, which are arranged one lying on top of the other and form the upper side and underside of a pouch that contains the product. At least one packaging material element is a tear-resistant film laminate with an at least three-layer structure, wherein at least one layer of the packaging material elements is a metal layer. The single-dose package also has a linear weakening, which lies in the sealing area, does not touch the edge of the package and extends in the direction of the weaker tear resistance of the upper side and underside and the linear form of the anisotropically tear-resistant plastic.

Tightly sealing single dose packaging

The present invention relates to a transmucosal administration system to administer quinones, benzoquinones, and especially 1,4-benzoquinones, via the oromucosal route.

Transmucosal administration system for a pharmaceutical drug

An edible orally disintegrating tablet 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 orally disintegrating tablet 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.

Edible oral strip or wafer dosage form containing ion exchange resin for taste masking

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.

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.

Wafer comprising steroid hormones

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&#xb0; 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.

Childproof highly-inert packaging for individually dosed films containing an active ingredient

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.

Childproof, highly inert individual packaging

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.

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.

Stackable bag packaging

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&#xb0; when considered from the main area of the individual zone.

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.

Packaging for active substance-containing films and method for producing them

Growing community of inventors

Neuwied, Germany

Markus Krumme