New compounds, delivery methods, Safety and Security are the current trends driving liquid dose drug manufacturing.
Liquid dose pharmaceuticals are most often formulated as solutions, suspensions or emulsions.1 Solutions are a homogeneous mixture where at least one substance is dissolved into another. Suspensions are heterogeneous mixtures with solid particles floating freely in a solvent. Emulsions involve ingredients which are normally immiscible, meaning that they are unblendable or unmixable. Orally administered drugs are traditionally found in glass bottles and delivered through cups, spoons, and droppers. Parenteral drugs, or non-orally administered drugs, are commonly delivered with a syringe that has been filled from a glass vial or ampoule. Many new advancements have been made to deliver more complex formulations beyond these traditional methods including increased shelf life and better control over the administered dose.
Many new compounds are complex, large-molecule formulations that do not remain stable very long after mixing. Lyophilization, or freeze drying, adds shelf-life to compounds which are unstable as a liquid. In this process, the materials are mixed and filled into a vial, usually in an aseptic, or sterile environment and transported to the freeze-dryers. The freeze-dried product can remain stable much longer which enables extended supply chains and larger inventories where the drug can reliably remain in a status where it is both safe and effective. Often, these products are packaged in a kit with diluent to reconstitute the freeze dried product. In addition to the increase in freeze-dried liquids, there have been advancements that combine delivery methods and packaging.2
Aerosols and foams can be used to deliver inhaled and topical drugs. Aerosols are released as a fine spray which is inhaled or applied topically. Foams are a mass of small bubbles. These products require special manufacturing and packaging equipment to combine the drug substance with a propellant and package them under pressure. Commonly used propellants in the pharmaceutical industry such as tetrafluoroethane or dichloromethane are generally not metabolized by the human body which makes them safe for use in drugs like commonly delivered via a metered dose inhaler.3 Aerosols and foams are commonly self-administered therapies which is another trend in liquid dose manufacturing and packaging.
Self-administered therapies are a driving trend in liquid dose manufacturing. The biggest advancements are unit dose vials and pre-filled syringes. These delivery methods provide pre-packaged doses of liquid products that a patient can administer themselves. Avoidance of office visits increases the likelihood of patient compliance and reduces costs. Unit-dose-vials are produced on blow-fill-seal (BFS) equipment. BFS equipment is a single machine were plastic resin is extruded, blown into a mold, filled and sealed. They can be operated in an aseptic environment for opthalmic products or inhalants that can be nebulized. Pre-filled syringes deliver the product pre-packaged in a syringe ready for patient dosing. The pre-determined doses ensure a safe dose of the product.
Safety and security are important considerations for any self-administered product. In addition to the product being safe and effective, the packaging must be robust and secure. Anti-counterfeit packaging validates that the product came from the proper source. Tamper-evident labels show the consumer that the product has not been compromised after manufacturing and packaging. Additionally, track-and-trace measures will use equipment to apply special labels with coding, and possibly, radio frequency identification (RFID) to ensure that the product can be traced back to the manufacturer.
All drug dosage forms rely upon delivery method and packaging to securely deliver a safe and effective product to the patient. New, life-saving compounds are being developed which require additional manufacturing steps to help them be available on the shelf when they are needed. Innovative delivery methods like aerosols and foams allow drugs to be delivered in novel ways. Self-administered drugs reduce costs and provide for accurate doses. While specialized packaging ensures that the product is what it says it is. All of these factors are driving the trends for liquid dose pharmaceutical manufacturing.
- Murthy, RSR and Kar, Ashutosh; Pharmaceutical Technology Volume-I, page 3. http://www.newagepublishers.com/servlet/nagetbiblio?bno=002130
- Nityanand Zadbuke, Sadhana Shahi, Bhushan Gulecha, Abhay Padalkar, and Mahesh Thube; Recent Trends and Future of Pharmaceutical Packaging Technology; J Pharm Bioallied Sci. 2013 Apr-Jun; 5(2): 98–110. doi: 10.4103/0975-7406.111820; http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3697200/
- Gold, Dr. Brad; Common Drug Propellants Undergo Insignificant Metabolism by Body, Metrics Scientist Says in AAPS Poster, November 5, 2014 http://metricsinc.com/common-drug-propellants-undergo-insignificant-metabolism-by-body-metrics-scientist-says-in-aaps-poster/
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