ISP Pharmaceuticals is a global business providing products and services for drug synthesis, drug solubilization, excipients and coatings. Built on a strong foundation of science and quality, ISP is committed to supporting the commercialization goals of producers of pharmaceutical products.
Our excipient portfolio, supported by strengths in formulation and physiochemical evaluation for oral solid dosage forms, includes Plasdone® polymers, Polyplasdone® superdisintegrants, cyclodextrins and Advantia® film coatings. To support our excipient products, ISP maintains nine full-service pharmaceutical laboratories around the world, providing the local support you need in countries where you maintain operations.
Tablet disintegrants
Polyplasdone crospovidones speed formulation development by providing the highest probability of formulation success. Not only are Polyplasdone crospovidones highly effective tablet disintegrants; Polyplasdone superdisintegrants can improve the rate and extent of drug dissolution. Polyplasdone XL-10 crospovidone has been shown to increase the dissolution rate of poorly soluble drugs compared with other superdisintegrants. And, as Polyplasdone polymers are nonionic in nature, they will not interact with cationic drug actives to retard drug release. Thus, Polyplasdone crospovidones are the disintegrants of choice for superior drug dissolution as well as tablet disintegration.
Tablet binders and dispersants for solid dispersions
Plasdone povidone polymers are the ‘gold standard’ in binder technology for wet granulation tablet processing. Plasdone S-630 copolymer is a highly compressible powder, making it an excellent tablet binder for direct compression and dry granulation. It is often used with poorly compressible actives to improve tablet breaking force and lower friability or to reduce compaction forces and tablet punch wear.
More recently, these polymers have been used in solid dispersions to increase solubility and thereby increase bioavailability of poorly soluble APIs. Plasdone K-29/32 povidone and Plasdone S-630 copovidone are highly effective polymeric dispersants and stabilizing agents for use in spray drying and hot melt extrusion solid dispersion applications.
One-step film coating systems
Advantia coatings are a family of one-step coating systems for immediate and delayed-release dosage forms, tailored to provide the performance and aesthetics required for an individual application. Advantia Coating Systems are supplied as pigmented or unpigmented powders in a wide range of colors. Coating suspensions are prepared in a single step, using water and simply applied using conventional coating process technology.
The newest edition to the Advantia coatings family, Advantia Preferred HS coatings provide significant improvements in film coating process productivity with high solids suspensions (up to 25%), exceptional tablet adhesion and an elegant tablet appearance.
Cyclodextrins
ISP offers a wide range of cyclodextrins, suitable for solid, liquid and parenteral formulations, for forming inclusion complexes with APIs. The resulting cyclodextrin-API inclusion complex has improved solubility and enhanced drug solubility.
Drug solubility services
With expertise in material science, ISP provides both ingredients and process technology services to improve drug solubility. ISP has expertise in solid dispersions, manufactured by melt extrusion or spray drying, for bioavailability enhancement, and provides development, clinical supply and commercial manufacturing services for spray-dried dispersion. With experience working with more than 100 actives in the last five years, ISP can assist with drug solubility challenges.
Contract manufacturing of APIs with low-temperature synthesis capabilities
For drug synthesis, ISP Fine Chemicals is a GMP contract manufacturing partner for APIs, regulated intermediates and key starting materials. For over 25 years, ISP has been offering a full range of reaction capabilities backed by highly trained specialists operating under well-tested cGMP systems.
Tetrahydrofuran reaction and extraction solvent
ISP is uniquely positioned among tetrahydrofuran manufacturers to understand the quality, logistics and service requirements of the pharmaceutical industry.