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.

Bilcare focusing on unique clinical packaging techniques

Counterfeiting of items and goods is a problem for many of us as it put our lives at risk and give a free pass to those opportunity seekers who initiate such things for their own financial benefit. Pharmaceutical industry is coming up with numerous techniques and methods to cope with such problems and contribute in the well being of people.

Bilcare is a research and packaging based service provider which is excelling in pharmaceutical industry since its establishment in 1987. Bilcare is involved in implementing numerous packaging techniques, keeping in mind the individuals’ requirements. Be it thickness packaging or child resistant, environment friendly or easy for senior citizen to use, Bilcare has solution for every needs. They are the foremost company in pharmaceutical industry regarding their clinical packaging. Keeping in mind the recent trends and demand in market, Bilcare have a dedicated team of Research experts and specialists whose main concern is to ensure the health of their end customers along with their own brand recognition.

Their current technologies and methodologies which they use in their clinical packaging involve:

• nonclonableID
• BilcareOptima
• BilcareBrandpack

These technologies are the state-of-the-art techniques which are used exclusively by Bilcare as they are discovered by their R&D experts.. Their foiling and filming processes are also one of a kind which is not like any normal foiling or filming. Their all packaging films solutions are free of cadmium, phthalates and lead stabilizers, which helps in maintain the quality standards of the end product. Bilcare is renowned globally for its continuous efforts for providing the innovative clinical packaging solutions to end customers which avoid counterfeiting.

Competitive advantages of clinical packaging

Contract clinical packaging providers say they are well positioned to sourcing the necessary medical components and delivering them in a suitable pack for end users. They represent a valuable resource for clients to outsource traditional in-house activities, or companies who have a limited packaging and distribution infrastructure. All claim to provide effectively the same global services.

For example, Almac claims its IRT solution positions it as the top global player in clinical supply chain management. Rondo-Pak reports having an experienced and professional design team to assist clients in the critical secondary packaging selection process. “We work closely with the client’s process engineers to ensure the packaging will run efficiently on their designated filling equipment,” Bani says. “In addition, we can offer traditional printed packaging components as well as fully assembled cartons for ease of use and (the) speed to market aspects of the trial process.”

PCI offers “seamless support” from clinical to commercial. “Our ability to support clients in taking a compound from clinical development to commercial launch within the same organization and on a global platform provides substantial value to our clients,” Misher says. “We add value by bringing commercial considerations, insight and expertise much earlier in the development process, while at the same time providing a single provider and continuity of services for bringing drug candidates to successful commercialization.”

Sharp reports it is positioned to provide all of the key services that comprise the clinical supply chain. “By fully integrating these services, we are able to satisfy a wide range of customers who are looking to consolidate vendors,” Morris says. “We are also more able to effectively reduce inherent risks in clinical timelines by reducing the interactions which can be created by a complex network of service providers.” These services include, among others, comparator sourcing, clinical label design/printing, package design, clinical packaging, global storage and distribution.

Bilcare talks about the basic functions of packaging

Packaging is a domain where pharmaceutical companies cannot afford to care less. A minor negligence can wreak havoc to the medicines. This is one prime reason why Bilcare conducts extensive research when it comes to packaging. Packaging performs a few functions that are paramount for the safety and stability of the drugs and medicines. Bilcare highlights a few important functions of packaging:

1. Containment of medicines: This is the most important function of packaging. The design of packaging must incorporate the needs of the product accordingly. The packaging and containment must ensure that the medicine doesn’t leak and the material used for packaging does not affect or permeate in to the product. The packaging must also be strong enough to contain the medicines when handled a little roughly. This needs the packaging to be robust. The packaging must also not be affected by the content of the medicines. They should be non reactive to each other.

2. Offering Protection: The packaging must ensure that the product stays unaffected and potent even if exposed to influences like light, moisture, oxygen and mechanical damages.

3. Stability: It is extremely important to ensure that the content stays safe and does not react with the packaging material. Bilcare conducts various tests to make sure that the primary packaging material and medicines are inert towards each other.

4. Storage: Packaging materials have to be designed depending upon the storage of the medicine stored in them. For example, if there is a medicine that needs to be stored within temperature range of 2-6 degree Celsius, it is important to design a packaging material that can sustain such temperature conditions.

Bilcare explains the general aspects of clinical packaging

Packaging is an intrinsic part of the pharmaceutical industry. One might argue that the life and effect of a medicine largely depends upon the packaging and this would be extremely hard to counter. This is because the way a medicine has been packed impacts the robustness of the product when being transported across miles. Packaging involves storing the medicines and drugs in bottles, vials, strips and using components like closure, cap, ampoule etc. There are a few important aspects regarding the process of packaging which Bilcare Limited lays emphasis on during clinical packaging:

• Selection of a material suitable for packaging
• Rigorous testing of the selected material
• Filling the containers and assembling
• Sterilization for safety
• Storage and stability

Packaging materials used by Bilcare or, as a matter of fact, by any other pharmaceutical company include printed material used for packaging a product. This however does not include any outer material that is used in the transportation of the product. The important thing is to differentiate between the primary and the secondary packaging materials. 

• Primary:  are in direct physical contact with the product.
• Secondary:  are not in direct contact with the medicinal content. eg:  caps, cardboard boxes etc

Containers could pertain to the category of primary or secondary, categorized by the usage. Containers could be well-closed, tightly closed, hermetically closed or light-resistant.

The packaging process consists of the following stages:

• Filling and assembling
• Sterilization in the final container
• Placing labels on the container
• Storage at the manufacturing and shipping sites.