#clinical packaging

[pharmasolutionsindia-blog]

Piramal Pharma offers specialized services in the area of clinical trial supply management using our global network of assets and expertise in streamlining the clinical trial packaging and supply process.

[vreema999-blog]

Piramal Pharma Solutions offers specialized services in the area of clinical trial supply management using our global network of assets and expertise in streamlining the clinical trial packaging and supply process.

[bilcareresearchtechnologies-blog]

Clinical Packaging at Bilcare Research

Bilcare has emerged as a best and well known pioneer company in terms of Clinical packaging and labeling. Bilcare has proven to be an able ally in delivering end-to-end services for your global clinical supply needs. Clinical packaging is a big concern for pharmaceutical companies in today's time. According to ICH guidelines the optimal amount of humidity and temperature has to be maintained while packaging, so that the formulation retains its stability. Not knowing what the exact packaging requirement for their products is, the pharma manufacturers often end up either packaging their product above or below the desired requirement. Above requirement means they purposely pack their formulation in high barrier packaging materials. This is done to reduce analytical workload and qualifying for the stability tests. However, over-packaging may unnecessarily add up to the packaging cost.

Bilcare's  unique approach enables us to support customer requirements for short-term studies as well as large-volume ongoing projects. This is irrespective of whether the requirement is from Phase I studies, that requires limited supplies or Phase III, requiring an almost bulk approach to packaging. This first and only scientific packaging development method understands the exact packaging requirement of the pharmaceutical formulations. This is done through a scientific study that quantifies the environmental and dimensional sensitivity of the pharmaceutical formulations. Thus, it identifies the optimum packaging of any pharmaceutical dosage by understanding the degradation pattern of the formulation and then correlating it to the barrier property of the packaging material without conducting the conventional stability studies. Bilcare then submits the report along with recommendations for primary blister packaging materials and a suitable back up packaging alternative for the product within 30 days time after initiating the study.

[clinicalpackagings-blog]

Bilcare Research expands its pre-clinical and early-stage development capabilities of clinical packaging

In its endeavor to accelerate the development process cycle resulting in enhanced “Speed to Market” for its clients, Bilcare Global Clinical Supplies, a leading single-source provider of Clinical Packaging, Clinical Trial Supplies and services, endorses its continual capability enhancement commitment by supplementing its ability of developing functionally viable and innovative formulation dosage forms for pre-clinical and early-phase drugs.

Vincent Santa Maria, President – Bilcare, Americas stated that as part of a major capital investment program at its facilities in the U.S., Bilcare Research has added sophisticated fluid bed granulation and enhanced capsule filling technologies to its R&D Center. “With this upgrade, Bilcare Research can now quickly produce a wider variety of drug dosage forms with high product quality at par industry benchmark. These investments in R&D services further prove our commitment to being a full-service partner to our global customers with the offering of a wide breath of specialty services like clinical packaging, continues Vincent.”

This capability enhancement compliments the increasing number of investigational new drug (IND) applications by innovator pharma and Biotech companies, which in turn requires multi-pronged expertise, more particularly in the Formulation and Analytical research and development, commented Praful Naik, Ph.D., Chief Scientific Officer, Bilcare Limited.

The fluid-bed granulation technology extends Bilcare’s solid dosage formulation capabilities. The granulation system equipped with Wurster coating inserts enables Bilcare to develop and deliver specialized coating processes for granules and non-pareils with high precision and consistency for creation of top quality sustained and controlled-release tablet and capsule formulations.

The In-Cap® capsule system, capable of filling several thousand capsules per hour in multiple permutations, is a versatile tool for pre-clinical and early-stage development. This equipment extends both development and clinical manufacturing capabilities for a myriad of formulation types including powders, pellets, tablets and liquids.

“Bilcare’s R&D center can now develop a broad array of dosage forms with innovative delivery mechanisms, which exceeds those developed by pharmaceutical companies,” says Frank Santillo, Ph.D., Bilcare Research’ senior director for research services. “Most importantly, we have the expertise to take a drug candidate from concept to clinical production without the client suffering critical and costly delays as a result of hand-offs, continues Frank”

About Bilcare Global Clinical Supplies

Bilcare Global Clinical Supplies serves the Americas, Europe, and Asia with clinical trial materials support, services, and complete project management. Its services for solid, semi-solid, liquid, DEA (CI-V), and biotech clinical trial materials (CTM) satisfy a broad range of requirements; from pre-formulation research and development, manufacturing, analytical services and clinical supplies clinical packaging and labeling, to IVRS, QP services, controlled temperature (cold chain) CTM storage, worldwide distribution, and returns and destructions accountability.

[clinicalpackagings-blog]

Clinical Packaging at Bilcare Research

Through comprehensive packaging research, Bilcare GCS produces customized and innovative clinical packaging materials. Bilcare GCS assists its clients in selecting appropriate packaging solutions through complete production and delivery.

Our packaging services are carried out by experienced clinical packaging professionals at our dedicated GMP compliant clinical packaging facilities: # Bottling (solids / semi-solids) # Blister packaging – any configuration # Cold form & thermoform # Blister card sealing and walleting # Pouching / powder filling # Label application and kit assembly # Controlled substance packaging (schedule I – V) # Ambient & controlled temperature (refrigerated / frozen) packaging # Tube filling # Creams # Ointments # Label printing with vision system.(Single panel,Multipanel booklet labels) Bilcare GCS' extensive clinical services experience and expertise actively supports and helps customers in the decision-making process to understand the long-term impact of packaging decisions.