Packaging a drug for clinical trials is distinctively different from pharmaceutical marketing packaging. There are various factors to consider, such as customer demographics, engineering techniques, regulations, package size, etc. For clinical trials, the laws are stricter, and both high and low volumes are required. A packaging company considers the following rules:
1.Use of Bio-Compatible Materials For Packaging:
Packaging companies might have to use bio-compatible materials for drug packaging to be eligible to get approved and meet the necessary standards. Almost every material used in primary and secondary packaging, including adhesives and glues, should all be bio-compatible. The suppliers generally have to prove the biocompatibility through datasheets. A clinical trial packaging company prepares the data beforehand to save time and labor hours.
2.Proper Labeling
Labeling is technical. The designers need to coordinate with engineers to ensure that it includes all the required text and necessary symbols.
For instance, if the syrup needs to be shaken before use, a significant symbol saying “shake well before use” must be on the package.
Moreover, messages like the relevant cautionary label may also be necessary for FDA’s approval. These rules are devised to ensure absolute consumer safety since pharmaceuticals can cause severe harm if they fail to convey essential information to the people.
Other important labels and symbols include:
- Name and place of business
- Serial number
- Quantity of product
- Description and use
- Warnings or hazards
3.Blinding Process
When a new drug is being compared to an FDA-approved drug during the clinical trials, the packaging design is blinded so that the effects of both drugs can be seen unbiasedly.
It is routinely used in randomized clinical trials as it helps minimize partiality in traditional trials.
Packaging aside, the practice of blinding is also implemented in general clinical trials to test the efficacy of a drug. Through it, the recipients do not know whether they’re taking a placebo or the actual drug. In this case, the administrator and the recipient are both unaware — making the results free of personal bias and placebo tendencies.
4. Adapt To New regulations
The regulations that supervise clinical trials are constantly under review, and continuously see reforms with time and new developments. Changes in rules pose new challenges for pharmaceutical companies related to package identification.
The clinical trial packaging companies remain up to date and consider the latest regulations in their processes.
5.Patient Compliance
Studies have shown that drug packaging plays a role in patient compliance. It can improve patient compliance in the following ways:
- Involving necessary information to make administration safe for the patients.
- Providing patient-specific instructions on the packaging like the dosage frequency.
- Making packaging designs easily accessible and readable, even for the elderly.
6.Smart Packaging
Drug packaging should also be tech-savvy to keep up with the rapidly changing digital world. Packaging companies should consider including barcodes that smartphones can scan. Ideally, smart packaging should also include digital technology such as labels with radiofrequency or near field communication (NFC) tags that can track the package transport times and usage information.
