Cover Story

Emerging Trends In Medical Plastics

Over filling of pharma API is a major cost especially in case of potent drugs. The conventional ampoule/vial needs 18-23% over filling to ensure accurate filling and dosing.

• However, in case of PFS, this overfilling drops down to as low as 2-3% thus saving significant raw material cost to the manufacturer This is observed more in case of biologics and potent drugs in which the cost of API forms the major cost of raw material used in the formulation.

• PFS being a single closed unit, is self sufficient and avoids additional medical waste unlike in ampoule/vial which needs a disposable syringe/ needle as an additional unit.

• This makes it possibleto cut down the waste formulation commonly called as ‘left over’ in the container. This reducing the medical waste.

• Being single dose, ready to use formulations, PFS makes it easier to use for a health care practitioner or the patient in case of self medication. Hence it has become a preferred choice due to ease of administration and convenience. This also helps in easy storage and disposal :

• PFS being packed at the manufacturer under sterile conditions and inspections, least contamination issues are observed. Cross contamination is also avoided being a single closed unit. This ensures prolonged sterility of the formulation until it is unpacked for administration.

• While breaking the ampoule, the glass flakes may go inside the container and thus not only contaminate the formulation but these sharp edges are also reasonably hazardous.

• In case of emergency situations in hospitals or mobile medical vehicles, PFS serves as life saving delivery systems due to minimum steps involved in administration of the drug as compare with conventional delivery system which is time consuming.

• Needle phobia is a major fear in the western world especially with women, children and geriatrics. PFS incorporates an almost hidden cannula thus avoiding the visibility of needle to the patient

• Color coding and individual labeling on the PFS ensure minimum human administration errors seen in case of multiple injection treatment and emergency situations.

• Different strength of same drugs are also color coding either at the barrel label or with different colored plunger rods.

• Every year over 3 million needle stick injuries take place globally. In case of PFS, these needle stick injuries are avoided as it allows a very natural handling and minimum time to fiddle with the syringe. This has a huge impact on preventing cross infections with HBC, HCV and HIV in public hospitals.

• Some multi dose delivery systems or storage containers like vials contain preservatives like Thimerosal as in case of Vaccines. PFS being single dose, avoids such unwanted ingredients in the formulation.

• Due to being a single container for storage and delivery as well, PFS ensures homogeneity within the formulation and hence a guaranteed dosage is administered as per the expectation from the label.

Some case studies in the past have shown the benefits of using PFS over conventional ampoule/vials. These are:

• In 1998, a study by a group in France demonstrated that using PFS over ampoule/vial saves 42% of administration time and justifies the additional cost of PFS

• In 2000, a study by a group in Canada demonstrated that using PFS over ampoule/vial saves 25% of administration time

• In 2010, a study at John Hopkins, USA demonstrated that using PFS over ampoule/vial saves over 70% of administration time in case of vaccines and over a dollar per dose

• A group in the Royal United Hospital UK, studied the cost effectiveness of PFS Thiopental against conventional delivery system. Most preferred drug in emergency obstetric anesthesia by 93% UK anesthetists. Of these 83% reconstitute it daily ensuring safety at the cost of increased wastage and expense. With PFS, shelf life increases to 90 days, and anannual cost saving of over 60% in spite of being 1.8 times more expensive than conventional formulation The above benefits look very lucrative but there are a lot of challenges involved in technically manufacturing a PFS. These challenges increase with the number of components involved in creating a single unit.Basically there are 5-6 components involved in a single unit of PFS which again depends on the material of construction of the barrel of a syringe, viz:
  - Luer Tip / Needle Shield
  - Luer Lock / Cannula
  - Barrel
  - Rubber Plunger
  - Plunger Rod
  - Flange
  - Thumb pad

• Various factors affect the design and synchronization of these components which together as a single unit make the PFS function. Some of these factors include:

- Different Kind of patients would have a different comfort level depending on the disease, age group, strength etc.
- User could be a patient (selfmedication), healthcare professional or the doctor himself
- Site of injection also influences the design and hence every different site needs to be customized
- Drug Viscosity, more the viscosity, stiffer plunger rod, and larger flange and thumb pad
- Needle Shield design – size, surface texture, material, grip, color, chemical properties, thickness
- Barrel design – Glass or Polymer, shape, grip, size, diameter, clearness, friability, strength, curvatures, surface texture, roll-ability
- Plunger Rod design – material, color, stiffness, structure, size, thickness, motion, stability
- Flange design – shape, size, grip, stiffness, material, grooved
- Label design – visibility, font size, color, material, transparency
- Thumb pad design – shape, size, surface slippery, strength, stability, edges
- Packaging – ease of pick up, unit size, handling
Its very important for all these components to function is reasonable synchronization. Even during the design stage, synchronization is of utmost importance. This is best achieved when all the components are made under one roof hence giving the best quality standards and control  uniform to each component. This also ensures zero dependency on an outside vendor thus significantly affecting the cost of the product.

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