Abstract: The present invention relates to a modified-release composition comprising orlistat and acarbose, comprising individually distinct parts with different release patterns: a) a first part, G1, comprising from about 5 to about 70% w/w of the total dose of acarbose, b) a second part, G2A, comprising from about 30 to about 95% w/w of the total dose of acarbose, c) a third part, G2B, comprising from about 10 to about 90% w/w of the total dose of orlistat, and d) a fourth part, G3, comprising from about 10 to about 80% w/w of the total dose of orlistat, and the total concentration of acarbose and orlistat, respectively, in the composition is 100% w/w.

Abstract: The present invention relates to a compressed pharmaceutical dosage form comprising one or more active pharmaceutical ingredients at a concentration between 2 and 15% w/w, porous particles, having a diameter between 1 and 100 ?m, at a concentration between 10 and 50% w/w and optionally one or more excipients. The active pharmaceutical ingredient is in admixture with and/or loaded into said particles, whereby a ratio of unloaded versus loaded ingredient is between 100:1 and 1:100. The porosity of the dosage form is more than 5% and less than 45% and the hardness of the dosage form is more than 5 N and less than 30 N using a Schleuniger hardness type tester.

Abstract: The invention relates to glucocorticoid replacement therapy and provides pharmaceutical compositions and kits designed to deliver one or more glucocorticoids to a subject in need thereon in a manner that results in serum levels of the glucocorticoid that essentially mimic that of a healthy subject for a clinically relevant period of time. The pharmaceutical compositions and kits are prepared in such a way that a first part of one or more glucocorticoids is substantially immediately released and a second part of one or more glucocorticoids is released over an extended period of time of at least about 8 hours. The invention also relates to a method for treating diseases requiring glucocorticoid treatment such as in subjects having a glucocorticoid deficiency disorder.

Abstract: The present invention relates to a modified-release composition comprising orlistat and acarbose, comprising individually distinct parts with different release patterns: a) a first part, G1, comprising from about 5 to about 70% w/w of the total dose of acarbose, b) a second part, G2A, comprising from about 30 to about 95% w/w of the total dose of acarbose, c) a third part, G2B, comprising from about 10 to about 90% w/w of the total dose of orlistat, and d) a fourth part, G3, comprising from about 10 to about 80% w/w of the total dose of orlistat, and the total concentration of acarbose and orlistat, respectively, in the composition is 100% w/w.

Abstract: The present invention relates to glucocorticoid-containing pharmaceutical compositions or kits for use in acute emergency situations where acute glucocorticoid therapy is required. Notably, the invention relates to pharmaceutical compositions and kits that are designed to be administered by non-medically trained persons outside a hospital or another medical or clinical setting. The invention also relates to a method for treating a disorder requiring acute glucocorticoid therapy by providing a fast onset of action of a glucocorticoid.

Abstract: The present invention relates to a modified-release composition comprising orlistat and acarbose, comprising individually distinct parts with different release patterns: a) a first part, G1, comprising from about 5 to about 70% w/w of the total dose of acarbose, b) a second part, G2A, comprising from about 30 to about 95% w/w of the total dose of acarbose, c) a third part, G2B, comprising from about 10 to about 90% w/w of the total dose of orlistat, and d) a fourth part, G3, comprising from about 10 to about 80% w/w of the total dose of orlistat, and the total concentration of acarbose and orlistat, respectively, in the composition is 100% w/w.

Abstract: Carboxymethylcellulose, notably sodium carboxymethylcellulose or other alkali metal or alkaline earth metal salts of carboxymethylcellulose, are employed to control solidification time of compositions comprising one or more bioresorbable ceramics, notably a hydratable calcium sulphate, in order to facilitate preparation of a ready-to-use composition for inserting into the body by injection.

Abstract: The present invention relates to a drug carrier composition comprising i) one or more biodegradable hydrating ceramics ii) one or more expandable agents, and iii) sorbed aqueous medium which in solid form has a ruptured structure. The function of the expandable agent is to create a ruptured structure in the solidified composition, either a foam-like structure or a disintegrated structure where it is split into a large number of parts, particles, units, granules or pieces, so as to obtain an enlarged apparent surface area that is exposed to degradation or erosion upon administration. Suitable substances to obtain this surface enlarging effect are gas-forming agents or swelling agents, gelling agents or disintegrants, here referred to as expandable agents. The expandable agents may be bioresorbable or non-bioresorbable.

Abstract: A novel method for the preparation of a highly densified and at least partly, preferably fully or almost fully hydrated ceramic for use in the preparation of a pharmaceutical composition notably for controlled-release of one or more therapeutically, prophylactically and/or diagnostically active substance. The method involves a concomitant step of hydrating and densifying a bioresorbable and hydratable ceramic such as calcium sulphate. The invention also relates to compositions comprising such a highly densified ceramic. The pharmaceutical composition is useful for targeted and controlled local prolonged release of active substances, e.g. anti-cancer agents, whereby the spectrum and severity of side effects are minimized due to an optimized local concentration-time profile.

Abstract: A method for treating prostate related diseases in a subject, the method comprising i) optionally administering to subject an initial boost dose of one or more active substances and/or prodrugs, and ii) administering locally into the prostate a controlled release pharmaceutical composition comprising one or more active substances in a biodegradable ceramic carrier. The biodegradable hydrating ceramic may be selected from the group consisting of non-hydrated or hydrated calcium sulphate, calcium phosphate, calcium carbonate, calcium fluoride, calcium silicate, magnesium sulphate, magnesium phosphate, magnesium carbonate, magnesium fluoride, magnesium silicate, barium sulphate, barium phosphate, barium carbonate, barium fluoride, barium silicate, or mixtures thereof. In a specific embodiment, the biodegradable hydrating ceramic is non-hydrated or hydrated calcium sulphate.

Abstract: The invention relates to glucocorticoid replacement therapy and provides pharmaceutical compositions and kits designed to deliver one or more glucocorticoids to a subject in need thereon in a manner that results in serum levels of the glucocorticoid that essentially mimic that of a healthy subject for a clinically relevant period of time. The pharmaceutical compositions and kits are prepared in such a way that a first part of one or more glucocorticoids is substantially immediately released and a second part of one or more glucocorticoids is released over an extended period of time of at least about 8 hours. The invention also relates to a method for treating diseases requiring glucocorticoid treatment such as in subjects having a glucocorticoid deficiency disorder.

Abstract: An injector device is disclosed, the injector device comprising an elongated mixing container extending along a first axis, and a piston member slidably positioned in the mixing container. The injector device comprises a mixing device comprising a mixing member, an elongated member parallel to the first axis and a handle member. The piston member comprises a piston head and a first locking arm flexibly connected to the piston head, such that the first locking arm in a first position extends substantially parallel to the elongated member and engages with the mixing device in such a way that the piston member moves in a first direction along the first axis with the mixing device. In a second position, the first locking arm may allow the mixing device to move relative to the mixing container independently of the piston member.

Abstract: The present invention relates to an improved method of administration of glucocorticoid based compositions in glucocorticoid replacement therapies enabling an objectively based regimen for administration enabling correct individual dosing of glucocorticoids resulting in an optimised individual replacement therapy and thus an improved long-term outcome for patients with temporary or chronic adrenal insufficiency.

Abstract: The invention relates to glucocorticoid replacement therapy and provides pharmaceutical compositions and kits designed to deliver one or more glucocorticoids to a subject in need thereof in a manner that results in serum levels of the glucocorticoid that essentially mimic that of a healthy subject for a clinically relevant period of time. The pharmaceutical composition comprises one or more glucocorticoids, wherein a first part of one or more glucocorticoids is substantially immediately released and a second part of one or more glucocorticoids is released over an extended period of time of at least about 8 hours, and the amount of the one or more glucocorticoids of the first part, expressed as hydrocortisone equivalents, is in a range of from about 15 to about 50% of the total hydrocortisone equivalents.

Abstract: The present invention relates to a drug carrier composition comprising i) one or more biodegradable hydrating ceramics ii) one or more expandable agents, and iii) sorbed aqueous medium which in solid form has a ruptured structure. The function of the expandable agent is to create a ruptured structure in the solidified composition, either a foam-like structure or a disintegrated structure where it is split into a large number of parts, particles, units, granules or pieces, so as to obtain an enlarged apparent surface area that is exposed to degradation or erosion upon administration. Suitable substances to obtain this surface enlarging effect are gas-forming agents or swelling agents, gelling agents or disintegrants, here referred to as expandable agents. The expandable agents may be bioresorbable or non-bioresorbable.

Abstract: The present invention relates to improved glucocorticoid therapy and to treatment or prevention of a number of disorders that are due to a diminished or disrupted endogenous glucocorticoid secretory pattern. The invention is based on the findings that producing a specific serum Cortisol time profile that mimics the circadian rhythm of Cortisol of a healthy subject in a subject suffering from a diminished or disrupted glucocorticoid secretory pattern gives benefits with respect to reduction of side-effects.

Abstract: The present invention relates to a drug carrier composition comprising i) one or more biodegradable hydrating ceramics ii) one or more expandable agents, and iii) sorbed aqueous medium which in solid form has a ruptured structure. The function of the expandable agent is to create a ruptured structure in the solidified composition, either a foam-like structure or a disintegrated structure where it is split into a large number of parts, particles, units, granules or pieces, so as to obtain an enlarged apparent surface area that is exposed to degradation or erosion upon administration. Suitable substances to obtain this surface enlarging effect are gas-forming agents or swelling agents, gelling agents or disintegrants, here referred to as expandable agents. The expandable agents may be bioresorbable or non-bioresorbable.

Abstract: Carboxymethylcellulose, notably sodium carboxymethylcellulose or other alkali metal or alkaline earth metal salts of carboxymethylcellulose, are employed to control solidification time of compositions comprising one or more bioresorbable ceramics, notably a hydratable calcium sulphate, in order to facilitate preparation of a ready-to-use composition for inserting into the body by injection.

Abstract: An injector device is disclosed, the injector device comprising an elongated mixing container extending along a first axis, and a piston member slidably positioned in the mixing container. The injector device comprises a mixing device comprising a mixing member, an elongated member parallel to the first axis and a handle member. The piston member comprises a piston head and a first locking arm flexibly connected to the piston head, such that the first locking arm in a first position extends substantially parallel to the elongated member and engages with the mixing device in such a way that the piston member moves in a first direction along the first axis with the mixing device. In a second position, the first locking arm may allow the mixing device to move relative to the mixing container independently of the piston member.