Portable Medicine Containers for Unchanged Efficacy - Assignment Example

Portable medicine containers for unchanged efficacy Contents Introduction 02 Stability 02 Computation of Temperature Effect on Efficacy 04 Material Selection 04 Design Concept 04 Decision Tree 06 Table of Asessment 07 References 09 Squeezing the efficiency of drug storage or shipment prompts new applications of value–added elements that determine patient outcomes and competitor edge. Roughly 85% of medications come in containers, pouches, closures, bottles or tubes. As a result, drug storage or shipment becomes a fragile point in the health delivery process that in itself, efficacy should remain unchanged at the same time consumption is raised. Prescription bottles first reached consumers in 1909 through a patent received by Thomas S. Obear. Back then, bottles came in oval shapes, graduated in both ounces and cubic centimetres (Griffenhagen et al, 1999). In these days, container designs for medications are a result of two disciplines: graphics and engineering, combined together to create better solutions for medication efficacy while these are kept. Innovations include contours with bump outs for easy patient grip when opening these containers, or removable rings for colour code prescriptions (Hafferty, 2010). Or, added ease with pliable ergonomic stoppers apart from utilisation considerations to protect product quality during shipment and in storage. Functionality involves structure, user friendliness in the simple dispensing of a dosage without need for assistance (Butchli, 2010); specialized packaging to unit-dose (Weeren et al 2002), labelling regulatory texts and standard brand imagery (Butchli, 2010). Given the broadness of available technologies, pharmaceutical containers sit a critical concern because efficacy directly affects health, impacts on brand differentiation and competitor edge. Containers protect against environmental factors as moisture, light or oxygen in the delivery of NDSS (Novel Drug Delivery Systems or medications described as oral, nasal, pulmonary, transdermal or needle free). The Institute for International Research has carried out several presentations on the relevance of a combined approach of scientific and business sense, and a marked cooperation between graphics and engineering to reach stability and shelf life (Weeren et al 2002). Qs: The efficacy of some medicines is dependent on the temperature at which they are stored. Design a portable container that will keep medication at approximately 40C for at least 12 hours. Stability Resistance to various physical or chemical reactions and contamination is the aspect of a drug known as stability. Typically, it is assumed that medications kept in closed containers remain unchanged within its shelf life. The rate of change or degradation is expressed in terms of, drug A which degrades by hydrolysis to degradant B thus A + H2O B Or reduction in the concentration of A with time is the same as the rate constant of the reaction K multiplied by the original concentrations of the reactants or rate equation —d[A]/ dt = K[A][H2O]. The effect of temperature escalates the rate of reaction on most medications. For instance, hydrolysis triples at a 10°C temperature rise. Oxidation affects mostly liquid preparations; shelf life can shorten by the frequency of uncovered concoctions. Other medications when exposed to light degrade as a result of photochemical reactions (Lowe, 2001). By regulation, the criteria of shelf life acceptance pertain to the restrictive conditions of medications in shipment and storage. Where applicable, this considers impurity that causes degradation of the product. Spoilage of medications due to physical changes is evidenced with discoloration, turbidity, gas formation, odours, loss of viscosity, or cracking of creams. While preservatives can be applied, its efficacy is raised proportionately to temperature (EMEA, 2006). Studies conducted on stability focus on product conditions in storage and shipment, on closures or pouches in 24 month experimentation under accelerated conditions of 40oC on solid oral dosage forms (Weeren et al, 2002). The table below presents materials selection and the degree by which these are affected by environmental factors. Table 1: Comparison of vapour and gas transmission rates on varying medicine container materials Source: Structure MVTR in gm-mil/100 in/ 24 hrs@100oF @90%RH Oxygen transmission In cc (STP) mil/100 un2/24 hr–ATM @77oF PVC/ aluminium foil/ polyamide (cold and foil) Aclar UltRx, SupRx, Rx PVC PE low density PE medium density PE high density Capran’ nylon Flourinated ethylene propylene Polyvinyl fluoride Polyvinylidene fluoride Polyester oriented 0.00 0.016 0.2 –0.6 1.0 –1.5 0.7 0.3 19–20 0.22 2.1 2.5 1.0–1.3 – 7 0.8–6.9 500 250–535 185 2.6 715 7.5 3.4 3.0–6.0 Computation of temperature effect on efficacy It is common practice to store medications under acceptable temperature limits. That is, quality and efficacy suffers whenever stored near heaters or in rooms having roofs without adequate insulation. Even yet, some drug substances require cold storage and constant temperature monitoring charted (Lowe, 2001). Calculations on the effect of temperature is expressed as S(T2) = S(T1) / Q10 S(T2) = S(T1) / (T2 - T1) Where S = shelf life at temperature T An example product requires refrigerated storage in mean temperature as 5°C and has 1 year of remaining shelf-life. The shelf life at 25°C is estimated using the equation Material options Materials selection could be cold formable or thermo formable with UV barrier or protection against water and oxygen that could damage medications before administration. Materials differ as to MVTR: moisture vapour transmission rate, typically made up of rigid polymer: PVC, PETG, APET, CPET, PP or COC and coated or laminated with coextrusion materials like Oxy Shield, PCTFE: polychloro-trifluoroethylene, PVDC: polyvinylidene chloride, aluminum foil, or EVOH: ethylene vinyl alcohol. Transparency is characteristic that remains desirable with particular benefits (Butschi, 2010). Ideally, the medicine container must preserve medications in 1—physicochemical properties or melting point, range, and refractive index, 2—particle size or substances that are solid, particle size effect on dissolution rates and stability, and 3 —polymorphic forms or drug substances in different crystalline forms which make up the quality or performance of the drug, bioavailability or stability (EMEA, 2006). Design concept The medicine container shall have a low temperature polymers tag that changes colour to provide visible indication of temperature variation beyond the predetermined stable temperature. The idea is not to use heavy technology or consume electricity in storage. Irreversible colour changing liquid crystals is an option, if these are available to preselected temperature. Any materials that prove practical as an indicator of temperature change can be used. The container walling shall be clear in colour and made of stiff, heat insulation material that can keep temperature at 4ooC for at least 12 hours. In size and shape this should be handy, light but firm to protect contents from being crushed. The exterior should not be water absorbent and the interior should be easy to clean. Contour should have adequate space to allow hands on the container while dispensing and enough legible label area. A stable base is a must, with soft, pliable cap. Adapting the removable rings for colour coded prescriptions is recommended. Conclusion It is for sure that the method is functional under certain temperature conditions but not in all regions, if ambient temperature is referenced. Experimentation is required to evaluate the viability of long term storage conditions using the container materials option and to conclude the design criteria is feasible. Temperature calculations on efficacy should be charted, compared and compiled, in the differing materials and indicative cost. Table 2 Assessment Matrix Oral delivery route characteristics: fast dissolving tablets or orally disintegrating dosage forms. Hygroscopic, polysaccharide or protein base taste masked. Fragile Pulmonary delivery route characteristics: inhalable delivery deep into lungs, either power or liquid. Can be fine powder with high surface area or aqueous/ non aqueous formulation Transdermal delivery route characteristics: sustained delivery or absorption through skin, depending on drug formulation Transmucosal delivery route characteristics: sustained delivery via mucosal layer. Moisture sensitive DESIGN CRITERIA MET Medicine container for temperature-sensitive medication which loses intended medical efficacy when subjected to a temperature or above a predetermined temperature Portable, to be carried by an “average” person Able to prevent the drugs from being crushed and getting wet Insulated Made of light-weight durable materials Possessing an interior that could be easily cleaned Keeping the temperature at 4oC for at least 12 hours Possessing a temperature monitoring and display device Capable of being used by people with little to no technical knowledge Aesthetically pleasing Designed with target users in mind; third world selected Safe for users and to limit property damage; no sharp edges TECHNICAL FEASIBILITY score +++ Stiff keeper for protection from mechanical forces Peelable opening feature Ultra-moisture barrier, aclar or foil to maintain shelf life stability for 2-3 years Medium high barrier protection Mechanical needs dependent on delivery device design Sterile barrier Chemical inertness for liquid doses Clear barrier offers QA check for both producer and end-user Protection from active environmental aggravates Clear barriers offers aesthetics Pouching as primary/ secondary package Barrier property on carrier web critical Chemical inertness Ultrahigh barrier moisture protection Clear material offers QA check Aesthetics RESOURCE FEASIBILITY score ++ Price is only one component of value, functionality could outweigh affordability Availability of materials to be used as indicators for temperature change TIMING FEASIBILITY score ++++ 85% of medications are shipped or hand carried by user before administration Concern on climate change has raised the issue of sturdy containers used in the process of health delivery Electrical consumption in the storage bin is not advised, nor the use of advanced technology to sustain heat About 20% of persons over 65 take 5 or more prescription medications Expanding applications in both solid and liquid l medications will create above average growth opportunities on containers , < Drug Delivery Technology> HUMAN FACTOR FEASIBILITY score ++ A tote size for purses and bags was also developed Eye catching More space to get hands on container while dispensing Stable base Clear, showing distinct label Cap stopper, soft and pliable Contour for easy grip Removable rings for colour coded prescriptions < Drug Delivery Technology> SOCIAL CULTURAL FEASIBILITY score +++ Design medicine keepers to improve patient independence, health, and longevity by simplifying the medication dispensing process and maintaining medication efficacy Persons requiring constant medications show impaired physical dexterity, poor cognitive skills and memory Scale of importance from 1 = unimportant to 5= high importance should be applied References Butschli, J. (2010), New frontier emerging in use of packaging to differentiate pharmaceuticals, , Butschli, J. (2010), Tube delivers differentiation, moisture barrier for RB’s Strepsils, , European Medicines Agency (2006), Specifications: test procedures and acceptance criteria for new drug substances and new drug products: chemical substances, EMEA London, UK, pp. 4, 25 and 32. Griffenhagen, G., Hagen, G., and Bogard, M. (1999), History of drug containers and their labels, American Institute of the History of Pharmacy, Madison USA, pp. 45. Hafferty, E. (2005) Clear RX design on drugs, , accessed 28 September 2010, sc.1-4. Lowe, R. (2001), Storage, stability and in-use shelf life guidelines, SPS London, pp. 1-12. Mohan, A. (2010), NACD awards honor innovation, Weeren, R., and Gibboni, D. (2002), Barrier Packaging as an Integral Part of Drug Delivery, Drug Delivery Technology Vol. 2 No. 4 June 2002, Montville, NJ, pp. 1-4. Read More