Product Development

CeutiPak LLC. has experienced personnel to assist in the development of parenteral dosage forms. We can  develop and fully document the entire production process. Furthermore, we can design your production process to provide the highest yield of finished product. Within this design, we can validate and establish PAT controls for your process.We have developed parenterals, topicals, and oral formulations across most therapeutic classes.

Our Development Team Can:

• Develop and validate analytical techniques for measuring concentrations of active ingredients and excipients

• Establish formulation procedures, precautions and controls that support a wide variety of formulation approaches

• Establish formulation procedures for parenterals, whether aseptically filled or terminally sterilized

• Perform stability studies according to current ICH guidelines in temperature-controlled storage areas to establish product shelf life

• Match drug, excipient and solvent systems with various filtration media to attain maximum compatibility and efficiency

• Establish validation procedures for manufacturing processes

• Evaluate container/closure systems to select those best suited as determined by product compatibility, reconstitution allowance, and batch size

• Establish PAT controls for your process

• Manage the transfer process from pilot batch to full scale production.

Many dosage forms have been developed and produced for both domestic and international markets. As a result, our analytical services include the testing specified in international pharmacopeias. These pharmacopeias include USP, JP, BP, and EP.

CeutiPak has experienced personnel to assist in the development of parenteral, topical, and oral dosage forms. We can develop and fully document the entire production process.

We have developed many products across most therapeutic classes.

Our Development Team Can:

• Develop and validate analytical techniques for measuring concentrations of active ingredients and excipients

• Establish formulation procedures, precautions and controls that support a wide variety of formulation approaches

• Establish formulation procedures for parenterals, whether aseptically filled or terminally sterilized

• Perform stability studies according to current ICH guidelines in temperature-controlled storage areas to establish product shelf life

• Match drug, excipient and solvent systems with various filtration media to attain maximum compatibility and efficiency

• Establish validation procedures for manufacturing processes

• Evaluate container/closure systems to select those best suited as determined by product compatibility, reconstitution allowance, and batch size

• Provide for orderly scale-up to full production volume to assure that the product can be manufactured efficiently. Many dosage forms have been developed and produced for both domestic and international markets. As a result, our analytical services include the testing specified in international pharmacopeias.

CeutiPak is well versed in the manufacture of parenterals, topicals, and orals. CeutiPak can enhance your company’s market position by offering a variety of products that include

Parenterals

Sterile filled unit dose products
Blow-Fill-Sealed products
Sterile filled ampules
Lyophilized products
Filled syringes

Topicals

Creams
Ointments
Lotions
Sprays

Orals

Soft gels
Capsules
Tablets