Brands

Shin-Etsu Chemical Co., Ltd. began to produce water soluble cellulose ethers in 1962, with the trade name METOLOSE®. METOLOSE® consists of Methylcellulose (methylcellulose USP) and three substitution types of Hydroxypropylmethylcellulose (Hypromellose USP) each available in several grades differing in viscosity. METOLOSE® can be used as a binder for solid dosage forms such as tablets and granules. It also provides a variety of functions such as water retention, thickening, protective colloid, surface activity, etc. It also can be used as a hydrophilic matrix agent. The hydrophilic matrix system is the simplest sustained release technology for oral dosage forms, consisting essentially of a drug and a water soluble highly viscous polymer. Recent advances in this hydrophilic matrix system have allowed more controllable and reproducible drug release by controlling the chemical and physical properties of the polymer. METOLOSE® SR is especially suitable for this application, and provides a genuine consistency in the final products.

TYLOPUR® is a versatile hypromellose, compliant with USP, JP, EP. The low viscosity grades are especially suitable for the design of film-coated tablet formulations. In addition, TYLOPUR® is effective as a binder, since it does not interact with drugs. It has superior stability, a non-ionic character and is widely used as a binder for granulation. Due to its plant derived nature and excellent moisture stability, TYLOPUR® replaces gelatin in hard capsule manufacturing.

Shin-Etsu Chemical's PHARMACOAT® was developed from hydroxypropyl methylcellulose in 1963, during the early days of film coating, and has been the subject of a continuous program of development and quality improvement since then. Film coatings of this type are now in widespread use throughout the world. Although drug properties are the key factor in medicinal formulations, the physical form or the finish of a preparation is also important. PHARMACOAT® is easy to use as a film coating material and gives an excellent finish. It is very versatile, and is suitable for many applications in the design of film-coated tablet formulations. In addition, PHARMACOAT® is effective as a binder, since it does not interact with drugs, and has superior stability, nonionic character, etc. PHARMACOAT® is widely used as a binder for granulation, and is available in various viscosity grades for granulation purposes. Shin-Etsu Chemical's PHARMACOAT® can make a valuable contribution in various areas of pharmaceutical technology.

L-HPC (low-substituted hydroxypropyl cellulose NF, JP, EP) This dual functioning excipient acts as both a disintegrant and binder. It is not the same as HPC.   L-HPC is insoluble in water. It is an effective disintegrant due to its swelling action in water. Because is has good compressibility, it functions as a dry binder.L-HPC benefits are:Enhanced stability because it is non-ionic and has low water activityIt is peroxide free and provides excellent compatibility for oxygen sensitive APIsImproved disintegrationA variety of grades are available depending on the application.

An enteric coating agent is used to protect drugs from degradation by gastric acid or to protect gastric mucosa from irritating drugs. HPMCP (Hypromellose Phthalate), since its introduction into the market in 1971 as an alternative cellulose derivative for enteric coating, has been demonstrated to be an effective and safe material by many researchers and is widely used as an enteric coating agent by the pharmaceutical industry. HPMCP has been admitted into the U.S. National Formulary (USP/NF), European Pharmacopeia (EP), and Japanese Pharmacopeia (JP). The chemical structure of HPMCP is a monophthalic acid ester of Hypromellose (hydroxypropyl methylcellulose), and the threshold pH value for rapid disintegration of HPMCP can be controlled by varying the phthalyl content. Two types of HPMCP with different in pH-solubilities, HP-55 and HP-50, are available. Moreover, HP-55S, a special type of HP-55, which is distinguished by its higher molecular weight, greater film strength and higher acid resistance properties, has also been introduced. A suitable grade of HPMCP for a particular purpose should be selected in accordance with each preparation.

Hypromellose acetate succinate (HPMCAS, NF, JP) is an enteric coating material that can be used in aqueous or organic media. Hypromellose is a non-toxic material which has been used in pharmaceutical, food, and cosmetic industries for many years. Based on hypromellose, acetyl and succinoyl groups are introduced to the hydroxyl groups of the backbone, and this constitutes Shin-Etsu AQOAT®, hypromellose acetate succinate (HPMCAS). There are nine grades with different particle sizes (fine, medium, granular) and chemical substitution levels of acetyl and succinoyl groups to obtain an opening pH range from 5.5 to 6.5. Shin-Etsu AQOAT® is the leading polymer in solid dispersion technology. It is suitable for spray-drying, hot melt extrusion, co-precipitation and other techniques. There are more than 14 approved products in the US using Shin-Etsu AQOAT® in solid dispersion. Additionally, we designed our HME cleaner to support you with trouble free cleaning after the extrusion process. Please contact us for further information.

TYLOPUR Xtend Nutra® is a plant derived ingredient (high viscous hydroxypropyl methylcellulose, HPMC) that has been developed by Shin-Etsu to provide a controlled, extended release of active compounds over a longer period of time, prolonging their effects on human body. TYLOPUR Xtend Nutra® acts as a hydrophilic matrix agent in hydrophilic matrix system, which is the simplest sustained release technology, consisting essentially of an active compound and a water soluble highly viscous natural polymer. Such a system allows a simple and straight forward direct compression formulation and a reduction of doses per day. It is not only cost effective but it is also consumer friendly. The mechanism of action of TYLOPUR Xtend Nutra® in hydrophilic matrix tablets consists of initial swelling caused by the hydration of a tablet, protective gel formation, which regulates the degree of active compound’s release, and time-related extended release of an active compound through the gel layer.

TYLOPUR ClearCoat Nutra® is a plant derived, water soluble ingredient (low viscous hydroxypropyl methylcellulose, HPMC) that has been developed by Shin-Etsu as a natural and easy-to-use material for film coating of nutraceutical and nutritional supplement tablets. It can be quickly dissolved in water at room temperature and does not require any additional ingredients for a successful coating. TYLOPUR ClearCoat Nutra® provides an excellent finish, that can protect tablets from humidity and reduces their overall friability during packaging. Moreover, coating with TYLOPUR ClearCoat Nutra® can improve the mouth feel and swallowability for consumers. Additionally, TYLOPUR ClearCoat Nutra® is recommended for wet granulation to improve particle size, powder flow and compressibility of nutraceutical actives.

SmartEx® is a co-processed excipient including L-HPC (disintegrant), polyvinyl alcohol (PVA, binder) and mannitol (filler). With good compressibility and rapid disintegration, as well as its free powder flow, SmartEx® is excellent for oral dispersible tablets (ODTs) by direct compression processes. A DMF is available.