Abstract: Knurled surfaces such as raised ribs are provided on the shell of a soft gelatin capsule in order to enhance gripping and manipulation of the capsule. The capsule has a removable tab at one end thereof which may also be provided with a knurled surface. One embodiment of the invention is a capsule used for delivery of medicaments to an external body surface. An alternative embodiment of the capsule is disclosed for insertion into a body orifice. The composition of the capsule includes a starch or starch derivative which gives the capsule a drier feel and increases the coefficient of friction of the surface of the shell, further improving the capsule's handling characteristics.

Abstract: Pharmaceutically acceptable solutions of acidic, basic or amphoteric pharmaceutical agents are disclosed. These solutions are suitable for encapsulation in gelatin capsules for subsequent oral administration and include the pharmaceutical agent, an ion species and a solvent system.

Abstract: A stepped-edge blister pack for containing and dispensing unit doses of medication such as capsules, tablets, caplets or fast-dissolving dosage forms (FDDF) is disclosed. The invention is comprised of a base sheet and a substantially planar lidding sheet. The base sheet has a plurality of blister compartments and a plurality of steps along its edges, one step being adjacent to each blister compartment. The substantially planar lidding sheet is peelably sealed to the base sheet except at extended edge regions, thus forming edge peel tabs, and the lidding sheet is scored with lines of weakening about each blister compartment. The steps along the edges underlay the unsealed extended edge regions of the lidding sheet, thus providing a series of finger accesses to thereby ease the process of grasping a given edge peel tab and ultimately opening a given blister compartment.

Abstract: A softgel having a texture on at least a portion of its surface and a process and apparatus for the manufacture thereof.

Abstract: This invention relates to a solvent system for enhancing the solubility of an acidic, basic, or amphoteric pharmaceutical agent to produce a highly concentrated solution suitable for softgel filling or two piece encapsulation. The solvent system comprises polyethylene glycol containing 0.2-1.0 mole equivalents of an ionizing agent per mole equivalent pharmaceutical agent and 1-20% water. Glycerin or polyvinylpyrrolidone may be added to further enhance the solubility of certain drugs. The disclosed solvent system is capable of enhancing solubilities of pharmaceutical agents 40-400%.The ionizing agent functions by causing partial ionization (neutralization) of the free pharmaceutical agent. When the pharmaceutical agent is acidic, the ionizing agent is preferably a hydroxide ion species, whereas when the pharmaceutical agent is basic, the ionizing agent is preferably a hydrogen ion species.

Abstract: A child-resistant blister pack for fragile single-dosage forms, e.g. a fast-dissolving dosage form ((FDDF) is disclosed. Limited entry points are provided, and completion of a sequence of steps is necessary to access the dosage forms within the depressions. A blister film sheet with depressions for receiving dosage forms is sealed with a lidding sheet and perforated to provide lines of weakness to define single dosage units with a depression containing a dosage form in each dosage unit. Single- or double-entry embodiments are disclosed, allowing access from one or two points on the blister sheet. After tearing along the perforations, a single dosage unit is separated from the blister pack. The user may then access the single-dosage form in the associated single-dosage unit. In a first embodiment, the dosage unit has a tear strip for exposing an unsealed corner, thereby allowing access to the dosage form within by grasping the edge and peeling it off the blister film sheet.

Abstract: A capsule for oral administration of a pharmaceutically active ingredient contains a pharmaceutical composition comprising the active ingredient, for example, a peptide, an absorption promoter and usually, a carrier. The absorption promoter is capable of enhancing absorption of the active ingredient from the intestine into the bloodstream. The capsule is coated with a film forming composition, which film is sufficiently insoluble at a pH below 7 as to be capable of protecting the capsule and its contents from the digestive juices until the capsule reaches a region below the upper part of the intestine, whereupon the coating and capsule are capable of eroding or dissolving to release the active ingredient for absorption into the bloodstream.

Abstract: Gelatin capsules of the type having an outer shell comprising gelatin and, optionally, a plasticizer, and a capsule filling, the filling containing at least one active substance and/or a dietetic agent or foodstuff as well as a solvent mixture, the solvent mixture containing about 5-50% by weight, preferably 10-30% by weight of ethanol and about 20-95% by weight, preferably 40-90% by weight of one or more of partial glycerides of fatty acids havig from 6 to 18 carbon atoms. The capsules are prepared by dissolving the active ingredients in the solvent mixture and filling the resulting mixture into the gelatin capsules.

Abstract: Soft elastic gelatin capsules containing primarily the crystalline form A of oxytetracycline hydrochloride exhibit increased storage ability.

Abstract: A capsule product and method for gradually releasing a medicament for absorption to a body of a warm blooded animal through the gastrointestinal system. The capsule has a fill material which includes a masticatory substance and a medicament that is dispersed throughout the gum. The medicament is of a type that is effectively and desirably released for absorption by the body through the gastrointestinal tract over an extended period of time. The masticatory substance forms a supporting cohesive matrix for the medicament. The gelatin shell, usually formed from gelatin, water, and a plasticizer, formed around the fill material into a capsule of a size and shape to be readily swallowable. Upon swallowing, the gelatin shell is rapidly dissolved in the gastrointestinal juices, while the fill material is substantially insoluble in the gastrointestinal juices.

Abstract: A pharmaceutical dosage unit form comprises one or more pharmaceutically active materials dissolved or suspended in a liquid polyethylene glycol and encapsulated in a soft gelatin capsule shell, in which the capsule shell comprises gelatin, a plasticizer therefor, and an embrittlement inhibiting composition comprising a mixture of sorbitol and at least one sorbitan. Preferably the polyethylene glycol also contains glycerin, sorbitol or propylene glycol.

Abstract: A soft gelatin capsule comprising a shell of gelatin and a softener, and a filling consisting of a polyethylene glycol and a low polyhydric alcohol and at least one active substance, characterized in that(a) the dried shell of the capsule contains 4 to 40% by weight of sorbital or sorbitanes;(b) at least 50% by weight of the polyethylene glycol used in the filling for dissolving or suspending the active substance is a polyethylene glycol having a mean molecular weight of 600; and(c) the capsule filling comprises up to 20% by weight of glycerol and/or 1,2-propylene glycol.

Abstract: A pharmaceutical preparation having an active substance of low solubility in water and gastric juices that has an initially liquid carrier system consisting of a hydrophilic component, a hydrophobic component and a solubilizer. The solvent mixture contains 9 to 90 parts by weight of solubilizer and 90 to 5 parts by weight of a hydropholic component, such as polyethylene glykol, 1,2-propylene glykol, 1,3-butanediol, 1,4-butanediol, 1,2-propanediol, glycerol, mannitol, sorbitol or polyoxyethylene polyoxypropylene copolymerisate or mixtures of such substances, and 40 to 1 parts by weight of an oleophilic component, such as natural and/or semisynthetic vegetable or animal oils or synthetic oils, such as neutral oil or waxes. The active substance is dissolved in the carrier system or dispersed in a stable way and for an oral application, is filled into drug capsules made of gelatine.