Abstract: Cysteine compositions comprising less than about 400 ?g/L of aluminum. For example, solutions of cysteine comprising a pharmaceutically acceptable solvent, cysteine, and less than about 145 ?g/L of aluminum, wherein the solution is devoid of visible particulate matter. Cysteine compositions described herein may be suitable for injection. For example, disclosed cysteine solutions may be provided intravenously to meet amino acid nutritional requirement in individuals receiving total parenteral nutrition. Also provided are processes for preparing cysteine compositions, and methods for providing cysteine to individuals in need thereof.

Abstract: The present disclosure provides drug-containing sustained-release particles that have minimal loss of the drug from the particle when the particle is formulated as a suspension in a liquid phase that is saturated by the drug.

Abstract: Cysteine compositions comprising less than about 400 ?g/L of aluminum. For example, solutions of cysteine comprising a pharmaceutically acceptable solvent, cysteine, and less than about 145 ?g/L of aluminum, wherein the solution is devoid of visible particulate matter. Cysteine compositions described herein may be suitable for injection. For example, disclosed cysteine solutions may be provided intravenously to meet amino acid nutritional requirement in individuals receiving total parenteral nutrition. Also provided are processes for preparing cysteine compositions, and methods for providing cysteine to individuals in need thereof.

Abstract: Cysteine compositions comprising less than about 400 ?g/L of aluminum. For example, solutions of cysteine comprising a pharmaceutically acceptable solvent, cysteine, and less than about 145 ?g/L of aluminum, wherein the solution is devoid of visible particulate matter. Cysteine compositions described herein may be suitable for injection. For example, disclosed cysteine solutions may be provided intravenously to meet amino acid nutritional requirement in individuals receiving total parenteral nutrition. Also provided are processes for preparing cysteine compositions, and methods for providing cysteine to individuals in need thereof.

Abstract: Cysteine compositions comprising less than about 400 ?g/L of aluminum. For example, solutions of cysteine comprising a pharmaceutically acceptable solvent, cysteine, and less than about 145 ?g/L of aluminum, wherein the solution is devoid of visible particulate matter. Cysteine compositions described herein may be suitable for injection. For example, disclosed cysteine solutions may be provided intravenously to meet amino acid nutritional requirement in individuals receiving total parenteral nutrition. Also provided are processes for preparing cysteine compositions, and methods for providing cysteine to individuals in need thereof.

Abstract: Cysteine compositions comprising less than about 400 ?g/L of aluminum. For example, solutions of cysteine comprising a pharmaceutically acceptable solvent, cysteine, and less than about 145 ?g/L of aluminum, wherein the solution is devoid of visible particulate matter. Cysteine compositions described herein may be suitable for injection. For example, disclosed cysteine solutions may be provided intravenously to meet amino acid nutritional requirement in individuals receiving total parenteral nutrition. Also provided are processes for preparing cysteine compositions, and methods for providing cysteine to individuals in need thereof.

Abstract: Cysteine compositions comprising less than about 400 ?g/L of aluminum. For example, solutions of cysteine comprising a pharmaceutically acceptable solvent, cysteine, and less than about 145 ?g/L of aluminum, wherein the solution is devoid of visible particulate matter. Cysteine compositions described herein may be suitable for injection. For example, disclosed cysteine solutions may be provided intravenously to meet amino acid nutritional requirement in individuals receiving total parenteral nutrition. Also provided are processes for preparing cysteine compositions, and methods for providing cysteine to individuals in need thereof.

Abstract: Cysteine compositions comprising less than about 400 ?g/L of aluminum. For example, solutions of cysteine comprising a pharmaceutically acceptable solvent, cysteine, and less than about 145 ?g/L of aluminum, wherein the solution is devoid of visible particulate matter. Cysteine compositions described herein may be suitable for injection. For example, disclosed cysteine solutions may be provided intravenously to meet amino acid nutritional requirement in individuals receiving total parenteral nutrition. Also provided are processes for preparing cysteine compositions, and methods for providing cysteine to individuals in need thereof.

Abstract: Cysteine compositions comprising less than about 400 ?g/L of aluminum. For example, solutions of cysteine comprising a pharmaceutically acceptable solvent, cysteine, and less than about 145 ?g/L of aluminum, wherein the solution is devoid of visible particulate matter. Cysteine compositions described herein may be suitable for injection. For example, disclosed cysteine solutions may be provided intravenously to meet amino acid nutritional requirement in individuals receiving total parenteral nutrition. Also provided are processes for preparing cysteine compositions, and methods for providing cysteine to individuals in need thereof.

Abstract: Cysteine compositions comprising less than about 400 ?g/L of aluminum. For example, solutions of cysteine comprising a pharmaceutically acceptable solvent, cysteine, and less than about 145 ?g/L of aluminum, wherein the solution is devoid of visible particulate matter. Cysteine compositions described herein may be suitable for injection. For example, disclosed cysteine solutions may be provided intravenously to meet amino acid nutritional requirement in individuals receiving total parenteral nutrition. Also provided are processes for preparing cysteine compositions, and methods for providing cysteine to individuals in need thereof.

Abstract: The present invention relates to novel microparticles formed of amphiphilic polyamino acids which transport active principle(s), AP(s), in particular protein and peptide active principle(s), and to novel modified-release pharmaceutical formulations comprising said AP microparticles. Microparticles of amphiphilic polyamino acid (PO) may include at least one AP (associated noncovalently) which spontaneously form a colloidal suspension of nanoparticles in water, at pH 7.0, under isotonic conditions. The microparticles may be obtained by atomization of a solution or colloidal suspension of PO comprising at least one AP, may have a size of between 0.5 and 100 microns, and may be dispersible in colloidal suspension.

Abstract: The present invention relates to novel pharmaceutical formulations based on aqueous colloidal suspensions for the prolonged release of one or more active principles, and to the applications, especially therapeutic applications, of these formulations. Formulations may include an aqueous colloidal suspension of low viscosity based on micrometric particles of a water-soluble, biodegradable, amphiphilic polymer carrying hydrophobic groups and ionizable hydrophilic groups that are at least partially ionized, said particles being capable of associating spontaneously and non-covalently with an active principle, at pH=7.0, under isotonic conditions. This suspension contains multivalent ions of opposite polarity to that of the hydrophilic groups, the ratio r, defined by the formula r=n×([IM]/[GI]), where n is the valency of said multivalent ions, [IM] is the molar concentration of multivalent ions, [GI] is the molar concentration of ionizable groups GI, being between 0.3 and 10.

Abstract: The present invention relates to a novel method for the preparation of nanoparticles with a diameter smaller than or equal to 500 nm, comprising bringing a solution (1) comprising nanoparticles of a first polyelectrolyte in the charged state, bearing hydrophobic side groups, together with (2) at least one second polyelectrolyte of opposite polarity to that of the first polyelectrolyte, characterized in that the ratio Z of the number of cationic groups relative to the number of anionic groups in the mixture of the two polyelectrolytes is comprised between 0.1 and 0.75 or between 1.3 and 2; and the total mass concentration C of polyelectrolytes is strictly less than 2 mg/g of the mixture.

Abstract: The invention relates to injectable long-acting insulin formulations for the treatment of types I and II diabetes in humans and animals. The essential object of the invention is to provide an injectable long-acting insulin formulation in the form of a colloidal suspension which is stable, which has a good local tolerance and toxicity compatible with the chronic treatment of diabetics, and which maintains a substantial hypoglycemic effect extending over at least 24 hours after a single administration, e.g. by the subcutaneous route. To achieve this object, the invention relates to a stable aqueous colloidal formulation of insulin-laden nanoparticles of at least one poly(Leu-block-Glu) in which the pH is between 5.8 and 7.0, the osmolarity O (in mOsmol) . . . : 270?O?800, and the viscosity v (in mPa·s) is low, namely v?40. The nanoparticles of poly(Leu-block-Glu) have a mean hydrodynamic diameter Dh such that: 15?Dh?40.

Abstract: The present invention relates to a novel family of polymers of acrylic and/or methacrylic type, comprising alpha-tocopherol grafts, capable of forming nanoparticles in an aqueous medium at a neutral pH. It also relates to the use of such nanoparticles, non-covalently combined with an active ingredient, in particular an active ingredient of low or average aqueous solubility, for conveying, solubilizing and/or increasing the aqueous solubilization of said active ingredient.

Abstract: The present invention aims to propose novel microparticle oral forms for the modified release of active ingredient(s), in particular protein or peptide in nature. It also relates to the uses, in particular therapeutic or cosmetic, of these microparticle oral forms.

Abstract: The invention relates to injectable long-acting insulin formulations for the treatment of types I and II diabetes in humans and animals. The essential object of the invention is to provide an injectable long-acting insulin formulation in the form of a colloidal suspension which is stable, which has a good local tolerance and toxicity compatible with the chronic treatment of diabetics, and which maintains a substantial hypoglycemic effect extending over at least 24 hours after a single administration, e.g. by the subcutaneous route. To achieve this object, the invention relates to a stable aqueous colloidal formulation of insulin-laden nanoparticles of at least one poly(Leu-block-Glu) in which the pH is between 5.8 and 7.0, the osmolarity O (in mOsmol) . . . : 270?O?800, and the viscosity v (in mPa.s) is low, namely v?40. The nanoparticles of poly(Leu-block-Glu) have a mean hydrodynamic diameter Dh such that: 15?Dh?40.

Abstract: The invention relates to injectable long-acting insulin formulations for the treatment of type I and II diabetes in humans and animals. The main objective of the invention is to provide a long-acting insulin formulation in the form of a colloidal suspension: which allows easy filling of a syringe through a small diameter needle (for example with the gauge 29 G, 30 G or 31 G) and/or which can be easily injected through a small diameter needle (for example with the gauge 29 G, 30 G or 31 G), without damaging the therapeutic efficacy of the insulin. To achieve this objective, the subject of the invention is an aqueous and stable colloidal formulation of nanoparticles of at least one poly(Leu-block-Glu), loaded with insulin, in which the pH is such that: 6.0?pH?7.

Abstract: The present invention relates to novel microparticles formed of amphiphilic polyamino acids which transport active principle(s), AP(s), in particular protein and peptide active principle(s), and to novel modified-release pharmaceutical formulations comprising said AP microparticles. The aim of the invention is to develop novel microparticles, charged with AP, obtained by aggregation of nanoparticles of amphiphilic polyamino acids and having improved properties, in particular in the dry solid form, with regard to their ability to be dispersed and, concerning the reconstituted suspension, its stability and its ability to be easily handled and injected. The invention relates firstly to microparticles of amphiphilic polyamino acid (PO) comprising at least one AP (associated noncovalently) which spontaneously form a colloidal suspension of nanoparticles in water, at pH 7.0, under isotonic conditions; which microparticles a.

Abstract: The present invention relates to novel pharmaceutical formulations based on aqueous colloidal suspensions for the prolonged release of one or more active principles, and to the applications, especially therapeutic applications, of these formulations. Formulations may include an aqueous colloidal suspension of low viscosity based on micrometric particles of a water-soluble, biodegradable, amphiphilic polymer carrying hydrophobic groups and ionizable hydrophilic groups that are at least partially ionized, said particles being capable of associating spontaneously and non-covalently with an active principle, at pH=7.0, under isotonic conditions. This suspension contains multivalent ions of opposite polarity to that of the hydrophilic groups, the ratio r, defined by the formula r=n×([IM]/[GI]), where n is the valency of said multivalent ions, [IM] is the molar concentration of multivalent ions, [GI] is the molar concentration of ionizable groups GI, being between 0.3 and 10.