parenteral excipients
delivery systems to control and protect
Parenteral excipients are inactive ingredients used in the formulation of injectable drug products (i.e., formulations delivered through intravenous, intramuscular, subcutaneous, or other non-oral routes). These excipients play a crucial role in maintaining the stability, solubility, and safety of the active pharmaceutical ingredients (APIs) in injectable drug formulations.
It is important that parenteral excipients are carefully chosen and evaluated for compatibility with the API, and for their safety and tolerability, considering the intended route of administration. Additionally, excipients should meet the requirements for injectable grade quality.
Ashland’s parenteral excipients include:
- viatel™ bioresorbable polymers that are the building blocks for long-acting injectable depots that improve therapeutic efficacy and patient compliance. They break down via hydrolytic degradation into the monomer components lactic and glycolic acid– both of which are either excreted by the kidneys or eliminated through well-known biochemical pathways.
Viatel™ Ultrapure high-purity bioresorbable polymers are extensively purified and contain extremely low residual monomer levels. For long-acting injectables and implants, these offer improved stability and achieve longer, more consistent drug release profiles; they are better suited for sensitive drug compounds in long-acting injectables and implants (LAII). - aqualon™ BET sodium carboxymethylcellulose product grades that are viscosity modifiers and excellent suspending agents, easily dispersible in water, and compatible with most active ingredients.
- cavitron™ cyclodextrins that increase the solubility and enhance the bioavailability of poorly soluble APIs.
- pharmasolve™ N-methyl-2-pyrrolidone (NMP) that is an excellent solvent used to increase the solubility of APIs and other ingredients, especially for two-component long-acting injectable depots and veterinary medicines.
- vialose™ trehalose dihydrate that is a common ingredient used to stabilize proteins by inhibiting degradation of the protein and its structure in biologic medicines.
- plasdone™ C-grades that are excellent solubilizers, crystallization inhibitors, and lyoprotectants for both small and large molecule APIs.
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cavitron™ and CAVASOL* HPBCD and HPGCD
The molecular structure of cyclodextrins creates a bucket-like cavity that can function to complex with molecules or functional groups on molecules. The substitution of hydroxyl groups on native cyclodextrins to make hydroxypropyl-ß- cyclodextrins (HPBCD) significantly enhances their solubility and makes them more suitable for drug solubilization. This mechanism makes the cavitron™ HPBCDs capable of masking unpleasant taste/odor and s...
plasdone™ povidone C grades
Ashland offers a comprehensive range of Plasdone™ povidones (PVP). Plasdone™ povidones are a family of water-soluble polymers based on N-vinylpyrrolidone that combine a unique set of properties for application in a wide variety of dosage forms. Plasdone™ povidones are commonly used as binders for the development of tablet formulations, whether manufactured by wet granulation, dry granulation or direct compression. Plasdone&trade...
pharmasolve™ n-methyl-2-pyrrolidones
Pharmasolve™ n-methyl-2-pyrrolidone (NMP) is a versatile solubilizer for one-component systems. It is a water-miscible polar aprotic solvent with high interfacial activity. Pharmasolve™ NMP is manufactured in a facility with ISO 9001:2015 and EXCiPACT GMP certifications. It is used as a drug solubilizer and penetration enhancer in human and animal parenteral dosage forms.
viatel™ bioresorbable polymer
Ashland offers a comprehensive platform of Viatel™ bioresorbable polymers for use in the pharmaceutical and medical industries. The platform portfolio contains many GMP grades, Viatel™ Ultrapure high-purity bioresorbable polymers for long-acting injectables and implants, and customized lactide/glycolide/caprolactone based polyester chemistries. In pharmaceutical applications, formulators typically use these polymers to formulate lon...
aqualon™ CMC PH BET sodium carboxymethyl cellulose
Aqualon™ sodium carboxymethylcellulose (cmc) is made by reacting sodium monochloroacetate with alkalicellulose under rigidly controlled conditions. The resultant anionic polymer is purified and dried. Purified cmc for personal care and cosmetic applications is typically sold at 99.5 percent minimum purity. In addition to thickening aqueous systems, cmc is used in personal care products for water binding, syneresis control and its ability to...
vialose™ trehalose dihydrates
who stabilizes your biologic for optimal health? we do a high purity grade of trehalose Vialose™ trehalose dihydrate is Ashland’s brand of trehalose dihydrate, a functional ingredient used to protect and stabilize proteins for biologic medicines and is the newest addition to Ashland’s portfolio of injectable ingredients. Vialose™ trehalose dihydrate is a high purity lyoprotect and stabilizer for ...
plasdone™ c-17 povidone
Plasdone™ povidones are a family of water-soluble polymers based on N-vinylpyrrolidone that combine a unique set of properties for application in a wide variety of dosage forms. Plasdone™ povidones are commonly used as binders for the development of tablet formulations, whether manufactured by wet granulation, dry granulation, or direct compression. Plasdone™ C grades can inhibit crystallization in injectable dosage forms.
vialose™ trehalose dihydrate
Vialose™ trehalose dihydrate is produced as a high purity excipient intended for injectable use and is tested to meet low levels of bioburden and endotoxin. The natural sugar composed of two glucose molecules formed by a 1,1 glycosidic bond is found in plant, microbial and animal species and serves as a source of energy and a protection against freezing and lack of water.
plasdone™ c-12 povidone
Plasdone™ povidones are a family of water-soluble polymers based on N-vinylpyrrolidone that combine a unique set of properties for application in a wide variety of dosage forms. Plasdone™ C grades can inhibit crystallization, improve solubility and modify rheology in injectable dosage forms.
CAVASOL® W8 HP Pharma
CAVAMAX® , CAVSOL® and cavitron™ cyclodextrins have the unique ability to act as molecular containers by entrapping guest molecules in their internal cavities. The resulting inclusion complexes are used in a number of applications in pharmaceutical formulations. For example, cyclodextrins increase water solubility of poorly soluble drugs to improve bioavailability, taste mask bitter actives for use in chewable and orally disintegrating tablet app...
cavitron™ w7 hp7 pharma cyclodextrin
CAVAMAX® , CAVSOL® and cavitron™ cyclodextrins have the unique ability to act as molecular containers by entrapping guest molecules in their internal cavities. The resulting inclusion complexes are used in a number of applications in pharmaceutical formulations. For example, cyclodextrins increase water solubility of poorly soluble drugs to improve bioavailability, taste mask bitter actives for use in chewable and orally disintegrating tablet app...
pharmasolve™ n-methyl-2-pyrrolidone
Pharmasolve™ n-methyl-2-pyrrolidone GMP grade can be used to improve the solubility of poorly soluble drugs and has a history of use with many medicines including human as well as veterinary products. Furthermore, in contrast to other drug-solubilizing agents, it has a favorable toxicity profile.
aqualon™ 7l2p ph bet sodium carboxymethylcellulose
Aqualon™ CMC PH BET acts as a suspending agent, rheology modifier and stabilizer. It is particularly useful as a suspending agent in two-component delivery systems. These high-purity grades of Aqualon™ sodium carboxymethylcellulose are produced and tested to meet low levels of bioburden and endotoxin.
aqualon™ 7lf ph bet sodium carboxymethylcellulose
Aqualon™ CMC PH BET acts as a suspending agent, rheology modifier and stabilizer. It is particularly useful as a suspending agent in two-component delivery systems. These high-purity grades of Aqualon™ sodium carboxymethylcellulose are produced and tested to meet low levels of bioburden and endotoxin.
aqualon™ 7mf ph bet sodium carboxymethylcellulose
Aqualon™ CMC PH BET acts as a suspending agent, rheology modifier and stabilizer. It is particularly useful as a suspending agent in two-component delivery systems. These high-purity grades of Aqualon™ sodium carboxymethylcellulose are produced and tested to meet low levels of bioburden and endotoxin.
cavitron™ w7 hp5 pharma cyclodextrin
CAVAMAX® , CAVSOL® and cavitron™ cyclodextrins have the unique ability to act as molecular containers by entrapping guest molecules in their internal cavities. The resulting inclusion complexes are used in a number of applications in pharmaceutical formulations. For example, cyclodextrins increase water solubility of poorly soluble drugs to improve bioavailability, taste mask bitter actives for use in chewable and orally disintegrating tablet app...
viatel™ bioresorbable polymers
Ashland’s Viatel™ platform of bioresorbable polymers are used in parenteral controlled release formulations. The Viatel™ portfolio contains many GMP grades as well as customized lactide/glycolide/caprolactone based polyester chemistries.In pharmaceutical applications, formulators typically use these polymers to formulate long-acting injectables (LAI’s) or controlled release systems which are typically realized in microsphere, nanoparticle, solid ...
viatel™ ultrapure bioresorbable polymers
Viatel™ Ultrapure high-purity bioresorbable polymers for long-acting injectables and implants offer improved stability and achieve longer, more consistent drug release profiles; they are better suited for sensitive drug compounds in long-acting injectables and implants (LAII). Removing residual monomer reduces acidic equivalents and results in a more consistent rate of water uptake and degradation kinetics. This means more reproducible performanc...