Ophthalmic preparations: Containers, Evaluation, IP products and MCQs for GPAT, NIPER, Pharmacist and Drug Inspector exam

Ophthalmic preparations: Containers, Evaluation, IP products and MCQs for GPAT, NIPER, Pharmacist and Drug Inspector exam

Packaging and containers: Eyedrops have been packaged almost entirely in plastic dropper bottles (the Drop-Tainer® plastic dispenser). The main advantage of the Drop-Tainer are:

  • Convenience of use by the patient
  • Decreased contamination potential
  • Lower weight
  • Lower cost
  • The plastic bottle and dispensing tip is made of low-density polyethylene (LDPE) resin, which provides the necessary flexibility and inertness.
  • The cap is made of harder resin

Advantage of LDPE resin:

  • Compatible with a very wide range of drugs and formulation components

Disadvantage of LDPE resin:

  • Sorption and permeability characteristics e.g. volatile preservatives such as chlorobutanol
  • Weight loss by water vapor transmission
  • LDPE resin is translucent, if the drug is light sensitive, additional package protection is required (using opacifying agent such as titanium dioxide)

A special plastic ophthalmic package made of polypropylene is introduced. The bottle is filled then sterilized by steam under pressure at 121°C.

The glass bottle is made sterile by dry-heat or steam autoclave sterilization.

Amber glass is used for light-resistance

Table 1 – Ophthalmic cap color coding

Color Pharmaceutical class
Yellow or blue Beta blockers
Grey Nonsteroids
Pink Steroids
Brown or tan Anti infectives
Orange Carbonic anhydrase inhibitors
Turquoise Prostaglandins
Red Mydriatics
Green Miotics

 

Evaluation of ophthalmics:

Evaluation of the opthalmic product is done by following tests:

1.Sterility test : Two basic methods for sterility testing:

Direct Inoculation Method: It involves the direct introduction of product test samples into the culture media.

Membrane filtration Method:  It involves filtering test sample through membrane filter, washing the filter with fluid to remove inhibitory property and transferring the membrane aseptically to appropriate culture media.

Detection of contamination used to two culture media:-

  • Soybean-casein digest medium:- Incubated at 20to 250C.
  • Fluid thioglycollate medium:- Incubated at 30 to 350C on 7 Days

2.Clarity test : Opthalmic Solution by definition contain no undissolved ingredients and are essentially free from foreign particles .

Visual Inspection: Under a good light, baffled against reflection into the eye and viewed against a black and white background with contect set in motion with swilling action.

Instrumental method: It is utilizing the principle of light scattering, light absorption and electrical resistance to obtain particle count and size distribution – destruction of product units- only for quality control testing. Instrumental method utilizing video image projection detects moving particles without destruction of product units-used for inline detection.

3.Leaker test : Select 10 tubes of the ointment with seals applied when specified. Thoroughly clean and dry the exterior surfaces of each tube with an absorbent cloth. Place the tubes in horizontal position on a sheet of absorbent blotting paper in an oven maintained at temperature of 60 ± 3 for 8 hours. No significant leakage occurs during or at the completion of the test. If leakage is observed from one, but more than one of the tubes repeat the test with 20 additional tubes of the ointment. The requirement is met if no leakage is observed from the first 10 tubes tested or if leakage is observed from not more than one of 30 tubes tested.

4.Metal particles in opthalmic ointment: Extrude as completely as practicable the content of 10 tubes individually into separate, clear, flat-bottom, 60-mm petridishes that are free from scratches. Cover the dishes and heat at 850C for 2 hours, increasing the temperature slightly if necessary to ensure that a fully fluid sate is obtained. Taking precautions against disturbing the melted sample, allow each to cool to room temperature and to solidify. Remove the covers and invert each petridish on the stage of suitable microscope adjusted to furnish 30 times magnification and equipped with an eye pieces micrometer disk that has been calibrated at the magnification being used. Examine the entire bottom of the petridish for metal particles. Count the number of metal particles that are 50µm on larger in any dimension. The requirements are met if the total number of such particles in all 10 tubes does not exceed 50 and if not more than 1 tube is found to contain more than 8 such particles. If these results are not obtained, repeat the test on 20 additional tubes. The requirements are met if the total number of metal particles that are 50µm on larger in any dimension does not exceed 150 in all 30 tubes tested and if not more than 3 of the tubes are found to contain more than 8 such particles each.

IP products:

Ofloxacin ophthalmic solution IP

Multiple choice questions:

1.Eyedrops have been packaged almost entirely in

a)plastic dropper bottles

b)plastic tubes

c)transparent tubes

d)all of these

2.The main advantage of the Drop-Tainer are

a)Convenience of use by the patient

b)Decreased contamination potential

c)Lower weight

d)All of these

3.The plastic bottle and dispensing tip is made of

a)low-density polyethylene (LDPE) resin

b)high-density polyethylene (HDPE) resin

c)low-density PVA

d)All of these

4.What is the advantage of LDPE resin?

a)Compatible with a very wide range of drugs and formulation components

b)Weight loss by water vapor transmission

c)Sorption and permeability

d)All of these

5.Disadvantages of LDPE resin is/are

a)Compatible with a very wide range of drugs and formulation components

b)Weight loss by water vapor transmission

c)Sorption and permeability

d)b and c

6.A special plastic ophthalmic package made of polypropylene is introduced. The bottle is filled then sterilized by steam under pressure at 121°C.

a)true

b)false

7.The glass bottle is made sterile by

a)dry-heat

b)steam autoclave sterilization

c)ethylene oxide

d)a and b

8.Which glass is used for light resistance packaging of opthalmics?

a)green colored

b)amber colored

c)transparent

d)all of these

9.Grey cap color coding is used for

a)Beta blockers

b)Nonsteroids

c)Steroids

d)Anti infectives

10.Pink cap color coding is used for

a)Beta blockers

b)Nonsteroids

c)Steroids

d)Anti infectives

11.Which of the following is not evaluation method for ophthalmics?

a)Sterility test

b)Clarity test

c)Leaker test

d)Pyrogen test

12.Which of the following are methods for sterility testing?

a)Direct Inoculation Method

b)Membrane filtration Method

c)Both of these

d)None of these

13.Which culture media is/are used for detection of contamination in sterility testing of opthalmics?

a)Soybean-casein digest medium

b)Fluid thioglycollate medium

c)Agar media

d)a and b

14.Incubation temperature for Soybean-casein digest medium is

a)20to 250C

b)25to 300C

c)30 to 350C

d)40 to 450C

15.Incubation period for Fluid thioglycollate medium is

a)7 days

b)14 days

c)21 days

d)15 days

Solutions:

  1. a)plastic dropper bottles
  2. d)All of these
  3. a)low-density polyethylene (LDPE) resin
  4. a)Compatible with a very wide range of drugs and formulation components
  5. d)b and c
  6. a)true
  7. d)a and b
  8. b)amber colored
  9. b)Nonsteroids
  10. c)Steroids
  11. d)Pyrogen test
  12. c)Both of these
  13. d)a and b
  14. a)20to 250C
  15. a)7 days

References:

  1. Remington Essential of Pharmaceutics, 1st edition 2013, page no. 555. 556.

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