Commercialization of any product edible or utilizable doesn’t happen overnight. Every commercial product needs to pass a series of tests to make sure that the product is actually functional and has zero hazards to the consumer. The testing procedure requires a number of criteria that ensures the use of the product only brings about good in the life of the user. This is the most important aspect in the manufacturing of edible product, especially pharmaceutical packaging. Where fruit pulp drinks and packaged food manufacturers have more concerns regarding the shelf life, pharmaceutical companies need to consider all parts of the product. From formulating the drug to packaging, pharma products can never be commercialized without tests.
An enhancement in medicine or procurement of a drug can take years of trials and studies before it can be put on the shelves. The tests conducted on any drug begin after the correct formulation of the drug is achieved. While consumer trials are being conducted, with safety measures, the packaging department works parallel to the drug manufacturing department. Its job is to make sure the drug is contained with protection from environmental factors and microbes. Also, the containers in which the drugs are stored must also be functional in aspects of drug delivery, sterility, counter display, etc. It all seems easy but choosing the right package for a pharma product is essential because no one would inhale an asthma pill from blisters or spray pain medication into their mouths. So here’s what to look for in the packaging material for your pharma product.
The Functions of Packaging Material
Before we go into the factors governing what packaging material is most suitable, we must look at the prerequisite functions of pharmaceutical packaging. It not only contains the drug but also enables protection. Here are some of the most important functions of packaging-
Containment
The packaging material that makes up the inner walls of any pharma package must ensure that the product is contained in a close system and does not spill, leak, or evaporate. There must be no diffusion or reactivity which ensues if the product is exposed to environmental agents like oxygen, moisture, or sunlight. The perfect packaging material thus ensures that there is no wastage of valuable dosage for any patient.
The closure system for any primary or containment packaging must be sturdy enough to hold the main product in common handling situations like- assembly, storage, transport and utilization by the doctor or the patient. For such conditions, simulation and test studies are conducted on the product after primary, secondary and even tertiary packaging (packaging used to ship products to the retailers or overseas). They assess all the possible situations of impact through drops, horizontal shocks, vibrations and compression, along with the limits of packaging being damaged.
Protection
Another important factor for a good pharmaceutical packaging material is the level of protection it provides. Pharmaceutical products are generally very reactive in nature and even the slightest contact with external factors can result in change of product quality, drug efficacy and in some cases poisoning too. With that in mind, it is essential for any pharmaceutical packaging material to be non-reactive with the actual drug that it envelops. Materials that cause altercations to the formulation of the drug are absolutely non-compliant. There are a variety of polymer and metallic materials that may react when introduced to the negligible heat and pressure produced by a pharma packaging equipment.
A good packaging material, used to make blister or containers, ensures safety of the patients too. It prevents a patient from consuming drugs that have been tampered or exposed to air or moisture. It also makes counterfeit drugs easily recognizable. Also, we know children can’t be supervised in every passing moments, meddling with medicinal drugs (or drugs of any sort) can be a trouble to the parent using the medicine. So to prevent the children from a mistaken intoxication or overdose (by bite or curiosity), container closures must be designed to safety standards.
Dosing and Use of the Product
Pharmaceutical packaging must be efficient at making management of dosages and there dispensing easier. Over the counter drugs, for example, must always have a dosage description for the consumers and should also include the formulation for the drug to help the pharmacist. A descriptive packaging is necessary in order to improve the compliance to the drug therapy during a medical issue.
In compliance to dosage and dispensing, blisters give a count of the pills and asthma pumps keep count of doses left to administer. This provides a simplicity to the patient and keeps track of refills or renewal of prescription. In order to achieve all of the above, it is essential to choose materials (in both primary and secondary package) that can be easily embossed without affecting the product. Aluminium bases and even PVC can be easily embossed today, while cardboard is still reigning at secondary embossed packaging.
Parameters for Choosing the Materials
There are a few important factors that any pharma manufacturer must consider before they choose a packaging material for their product.
Dosage form of the product
Dosage form of the product is an essential factor if one is to determine the packaging that is most suitable. Drugs that are administered parenterally i.e. intravenously or intramuscularly are always in the form of injections connected to syringes. Such products always need to be packed in a glass vial with a rubber stopper or aluminium cap. Sometimes these products are also packaged in single use glass syringes.
Tablets and capsules that are administered orally are generally packed in PE Bags when there has to be bulk storage at the warehouse or at a registered clinic. When a tablet or capsule is supposed be supplied direct to retailers for over-the-counter sales, they are always packaged in blister packs. Blisters packs are customarily manufactured out of polyvinylchloride (PVC), polyvinylidene chloride (PVdC), Aclar (fluoropolymer), or Aluminium. All of these materials have proved over the years that they aren’t reactive to the agents present in the drugs. Most American countries use plastic bottles for pills. Glass bottles are mostly used for the packaging of liquefied oral dosages like syrups, tonics and oils. Because glass has perfect protective properties against leakage and contamination.
Properties of the pharmaceutical drug
It is important to examine all characteristic properties of the drug that is being packaged before you select a packaging material. It is important to note the sensitivity of the drug when it’s exposed to several external factors such as heat, air, moisture, oxygen, light, and even to the packaging material decided in the initial stages. Considering these factors will always help the drug in retaining its healing quality and potency.
The perfect packaging material will always protect the drug from deterioration and will keep the formulation of the drug stable until the expiration date reaches. Some drugs for example are prone to reactions when they encounter certain wavelengths of light. When that is the case, a transparent blister or glass bottle just won’t cut it. There must be coloured polymers or amber coloured glass bottles rather than transparent ones to keep destructive light waves out. The best solution would be to use an aluminium blister packaging or aluminium lids on bottles to protect the drugs from radiation, light, and even moisture. Ethylene Vinyl alcohol is another useful substance that can be used in pharma packaging to prevent drugs from getting exposed to oxygen.
Since a majority of medicinal drugs are formulated with chemical and reactive agents, tests and studies are important to be conducted. After all the medicine must be constructive in recovery and not the other way around.
