The objective of the present invention is to provide a capsule filling composition which can stably produce a capsule formulation by suppressing the flow of components out of the capsule body during capsule filling, regardless of the compressibility of an active ingredient such as drugs and health foods, so that a favorable capsule filling can be achieved; and a method of producing a capsule formulation with the use of such a capsule filling composition, as well as a capsule formulation. The objective is achieved by a method of producing a capsule formulation, comprising subjecting a capsule filling composition containing an active ingredient and a cellulose ether powder to a funnel system powder filling or a die-compression system powder filling to obtain the capsule formulation, and the like.

Low dose pharmaceutical formulations may be prepared to deliver consistent low doses of a variety of pharmaceuticals with minimal additives. In particular, the low dose pharmaceutical formulations are solid unit dosage forms of low dose drug substances which may be prepared by a method that provides content uniformity across prepared solid unit dosage forms.

The present invention provides engineered lipase polypeptides and compositions thereof. The engineered lipase polypeptides have been optimized to provide improved thermostability, protease stability, and stability under a range of pH conditions, including acidic (pH<7) and basic (pH>7) conditions. The invention also relates to the use of the compositions comprising the engineered lipase polypeptides for therapeutic and/or nutritional purposes. The present invention also provides polynucleotides encoding the engineered lipase polypeptides, as well as methods for making the engineered polynucleotides and lipase polypeptides.

The invention relates to bioavailable pharmaceutical compositions having increased dose loading and improved dissolution less subject to a food effect.

A package for delivering a single-dose product includes a softgel capsule which is comprised of at least one gelling agent selected from protein-based gelling agents and polysaccharide-based gelling agents. The capsule shell includes one or more areas of reduced thickness that are preferentially ruptured by exertion of a compressive force on the softgel capsule to create an opening in the capsule shell through which the fill composition can be delivered by spraying or squeezing. A method for manufacturing the softgel capsule having one or more areas of reduced shell thickness is also described.

A method for the production of pullulan soft capsules eliminates the need to dry pullulan solid product, thereby reducing the equipment cost and energy consumption. The pullulan raw material production can be linked directly with the soft capsule production to provide a unique approach for soft capsule formation. The purified pullulan fermentation fluid can be directly used in soft capsule preparation, thus removing the need for a melting process. On the one hand, the method can decrease material consumption, save the cost of equipment and labor, reduce production time and increase productivity. On the other hand, the method can reduce the fluctuating of raw material quality in the re-melting process and guarantee a more stable soft capsule production and quality.

The invention relates to a process of preparing a salt of an active pharmaceutical ingredient, the process comprising providing a blend of an active pharmaceutical ingredient and a salt forming substance, mixing the blend, optionally in the presence of added water, to react the active pharmaceutical ingredient with the salt forming substance to provide the salt of the active pharmaceutical ingredient; wherein when the active pharmaceutical ingredient is acidic, the salt forming substance is a base and the pKa difference between the acidic active pharmaceutical ingredient and the base is greater than 1, typically greater than 2 or preferably greater than 3; or when the active pharmaceutical ingredient is basic, the salt forming substance is an acid and the pKa difference between the basic active pharmaceutical ingredient and the acid is greater than 1, typically greater than 2 or preferably greater than 3.

A method for the production of pullulan soft capsules eliminates the need to dry pullulan solid product, thereby reducing the equipment cost and energy consumption. The pullulan raw material production can be linked directly with the soft capsule production to provide a unique approach for soft capsule formation. The purified pullulan fermentation fluid can be directly used in soft capsule preparation, thus removing the need for a melting process. On the one hand, the method can decrease material consumption, save the cost of equipment and labor, reduce production time and increase productivity. On the other hand, the method can reduce the fluctuating of raw material quality in the re-melting process and guarantee a more stable soft capsule production and quality.

There are provided a coating composition for applying inkjet printing thereto to form a marked preparation, the composition providing good ink affinity, suppression of ink bleed, and excellent gloss; and others. More specifically, there are provided a composition for applying inkjet printing thereto to form a marked preparation, the composition including a water-soluble cellulose ether having a viscosity at 20 C. of from 2 to 50.0 mPa.Math.s, as determined in 2% by mass aqueous solution, polyvinyl alcohol, and a solvent, wherein a mass ratio of the water-soluble cellulose ether to the polyvinyl alcohol is from 99.0:1.0 to 55.0:45.0; a method for producing a preparation marked with aqueous ink, including a coating step of coating an object with the composition to form a coating layer, and a printing step of inkjet-printing on the coating layer with aqueous ink to obtain a preparation marked with aqueous ink; and others.

New soft capsules are described having within them a fill which contains thyroid hormones such as thyroxine T4 or triiodothyronine T3) and a high amylose-starch, optionally associated with vegetable hydrocolloids and/or glycerol. Compared to traditional capsules, these capsules have a strong and unexpected increase in the stability of T4 or T3 during storage.