Packaging Management of Drug Products for Clinical Use

Clinical products in the Pharmaceutical industry form the basis of drug development, research, and solving drug-related problems. It provides critical data related to product characteristics that researchers and developers use to curate the string of actions during the entire product life cycle.

For managing pharma products related to clinical trials, specialized procedures are required compared to commercial pharma products. Some areas include database, registration, product manufacturing, quality, and marketing.

Packaging for Clinical Drugs

Pharma products for clinical purposes also require specialized packaging procedures compared to commercial products. It requires careful selection of primary and secondary packaging materials and final distribution practices that fulfill particular patient requirements, productivity, and efficiency.

Clinical drug products also require specialized secondary packaging. It should protect the product from extreme environmental conditions because clinical products contain specialized functions delivered in specialized packagings, such as PFS or lyophilized products. Secondary packaging should also protect the product from harsh external conditions because recipients of these products are located in geographical locations of every weather condition.

Let’s to discuss how packaging of clinical drug products are managed

Carton or final packing

Carton or final packaging refers to the packaging that contains more than one primary pack product. It is primarily used for distribution purposes to its intended user’s location.

Carton or final packing should be able to protect the product from breakage, contamination, and extreme environmental conditions such as heat or cold. Additionally, the product inside can be easily identified. Depending on the dosage requirements, it should be effortlessly combined to form a desired dosage. The product should be easily managed without excessive human involvement or force.

This carton must be of appropriate dimensions so that standard primary packaging units can fit inside them. The carton or final packing can be easily picked up or handled by humans.

Labels

Labels indicate and mark the clinical drugs for their desired purpose. They also mention the user for which the drug is intended. Because clinical drugs are not manufactured for the general public and require the selection of patients. Labels indicate the product's specific purpose by marking it with a specific mark of identification. More importantly, the label should state that the drug is only for clinical purposes and cannot be consumed under regular drug requirements. The label's language must be accessible and understandable by the patients or people who could interact with the product, such as relatives, wives, and husbands.

If clinical trials involve the protection of the patient's identity, the labels should not disclose any information relevant to the patient. Instead, for identifying patients, a coding system should be used to reach the drug to its desired destination. There can be many coding forms, such as a barcode or QR code.

The label should contain the following information.

• Detail of sponsor or investigator conducting the research

• Instructions that the product is intended for clinical research purposes

• Product identification details, such as

• Product Name

• Product batch number

• Product serial number

• Manufacturing date

• Target patient details or relevant coding system

• Direction for using product, specifically if product requires special instruction

• Storage information, with complete detail

• Expiry date or Best before

Pragimary Packing

The selection of primary packaging material depends upon the clinical product, as these are under investigation and have specialized product characteristics. This requires careful selection of primary packaging material. Primary packaging must provide product safety against a number of factors, such as human handling and environmental conditions. Primary packaging must retain product qualities and properties without creating difficulty for the patients. The primary packaging should protect the product against damage and contamination.

Primary packaging material for clinical use must provide child-resistant features and prevents opening by children, intentionally or unintentionally.

An example of primary packaging material for clinical products is pre–filled syringes. It consists of a container that is pre-filled in a filling machine. PFS can be administered directly without using any external device, such as a syringe. PFS can be administered directly to patients.

Specialized packaging features

Clinical drug packaging is provided with specialized features to perform specific functions, often not with normal packaging. These features also help investigators fulfill challenges and obstacles faced during clinical trial studies.

Among many challenges is the patient’s nonadherence to practice. Specialized features help to identify patients who participate in clinical trials but do not take a major portion of the medication. There can be multiple reasons for not adhering, such as the patient forgetting to take medication or the unavailability of the drug during that particular time. Since patients have not consumed the drug, it affects the reliability of the clinical study. It can also cause variation in the outcome of the study. Other disadvantages of nonadherence include a higher cost and reduced effect of treatment.

Another major problem during clinical trials is the storage conditions. Temperature-sensitive products, such as biological or vaccines, lose their efficacy if desired temperature conditions are not provided. It is critical for these products to be stored under tight temperature conditions.

Packaging with special features prevents these problems and others like this. Also called smart packaging, they use the latest technology, such as RFID and barcode, to track different properties such as storage conditions and patient usage cycle. They can also record drug usage history. Smart packaging can also include sensors that can track biological or chemical activity in the pharma product. These sensors can provide valuable information to the patient, such as if a drug has expired or becomes dangerous for consumption.

The features of smart packaging can alert the patient or other persons if products specific requirements are not fulfilled or being provided.

Difference between packaging of clinical packaging and commercial packaging

The clinical products requires specialized packaging, as discussed above, which are different than that of commercial products. Let’s discuss some differences between these two packaging types

Marketing VS usability

Non clinical products packaging are designed according to the company’s marketing theme and campaign, in addition to product’s safety and efficiency. These products represents the marketing strategy of the organization and act as branding for that organization. Packaging without branding or if the packaging design strategy is not at par as compared to its competitors, it is considered negative strategy for that organization. Similarly, packaging designs, layout, dimensions and typography are also the brand representation of an organization.

Packaging for clinical products is designed considering the products usability. It means packaging is designed and developed in a way that best suits the patient’s requirement. It provides maximum ease to its patients so that patients can easily consume the drug. It provides user-friendly features, and avoiding those that can cause any difficulty for the patient. The appearance of packaging is not market friendly. Rather than it contains information that is important and critical for patients are humans.  Similarly labeling also serves usability by providing patient centric information in a more convenient and understandable way

High Volume VS Low Volume

Commercial products are produced in large volumes or batch quantities. The raw material is required in large quantities ahead of time to meet market requirements. The raw material can be stored in a warehouse under appropriate storage conditions until its expiry date. Similarly, packaging material can also be arranged in large quantities. These products have well-developed and approved production procedures that can be reproduced every time. All the above features allow commercial products to be manufactured in large quantities without the danger of recall or damage.

Clinical products are produced in low-volume quantities. The main reason is that since these products are under trial, fewer patients exist. These patients consume fewer drugs and cannot exceed a specific quantity in a given location or market. Another reason is that since these are under trial, there are no approved procedures for production, packaging, storage, and other related processes. Procedures for these processes can change depending on the trial's outcome or the patient's condition as the trial advances to its various stages.

Blinding

Commercial products contain accurate information about the drug being administered. The patient knows precisely what type of drug they are being given with the actual quantities of active end relevant chemical composition. The main reason is that these drugs have passed the clinical trials phase with the required test amendments in the product or process. This makes the pharma product effective in curing certain diseases and provides confidence to the patients regarding the drug output. This prevents bias in the patients or other relevant persons regarding the pharma product output.

Drugs for clinical trials are subject to blinding, which involves restricting the access of drug information to patients or relevant persons. Its primary purpose is to prevent bias towards the pharma product. There can be many reasons for biases, such as previous bad experiences with certain products, attraction to a specific product, and liking or disliking of pharma products. These factors affect the clinical trials, and the final result can deviate from the actual result. These drugs are subject to blinding to minimize the bias towards clinical pharma products. This prevents patients and others from getting information about the drug and developing a natural behavior without fear, bias, or likelihood.

About the Author

Muhammad Asim Niazi has a vast experience of about 11 years in a Pharmaceutical company. During his tenure he worked in their different departments and had been part of many initiatives within the company. He now uses his experience and skill to write interested content for audiences at PharmaSources.com.