Page 11 - FAR 222 Laboratory Manual V2 2019
P. 11

FAR 222/3 Dosage Form II                                            Semester 1/ 2019-2020


                  Exercise 1.1
                   Neomycin eye drops
                   sig. iv gtt. pro ocul. dext. o.m. × 2/12

                                                                           ∆         E1%       NaCl Eqv
                         BPC formula         100 mL          30 mL
                                                                          T/°C
                      Neomycin sulphate       0.5 g         0.15 g*       0.063  0.063/0.576=  0.109x0.5=
                            0.5%                                                    0.109       0.0545%
                   Na acid phosphate 0.7%     0.7 g          0.21 g       0.207     0.359       0.2513%
                      Na phosphate 0.7%       0.7 g          0.21 g       0.127     0.220       0.154%
                       PMN 0.002%w/v                      3 mL (0.02%
                           solution           0.002%         stock)
                    EDTA 0.01% (optional)     0.01%         0.003 g*      0.132     0.229      0.00229%
                                                                                               0.9-0.462=
                      NaCl for isotonicity   0.438%         0.131g
                                                                                                0.438%
                                            qs ad 100                                           0.462%
                        Distilled water                      30 mL
                                               mL                                              NaCl Eqv
                  *need dilution

                  Eye can tolerate 0.5% to 2% NaCl. Necessary to adjust isotonicity with NaCl.

                  Method
                  1.  Weigh/measure all ingredients.
                  2.  Dilution performed accordingly for MWQ. Prepare dilution for neomycin & EDTA.
                  3.  Add all together in measuring cylinder.
                  4.  Top up with d.water to 30 mL. Mix well.
                  5.  Filter using sintered glass filter grade 3.
                  6.  Check solution using Allen viewer for any particles.
                  7.  Transfer 10 mL of the solution into eye drops bottle using a rinsed measuring cylinder.
                  8.  Close the bottle with closure.
                  9.  Sterilise the preparation by Method B (aseptic filtration) or C (heating with bactericide at 98
                      – 100 °C for 30 min).
                  10. Label the preparation.

                  Label
                                                          10 mL
                                             NEOMYCIN SULPHATE EYE DROPS
                                                         0.5 %w/v
                              Bactericide: PMN 0.002%w/v
                              FOUR (4) drops to be applied to the right eye every morning
                              For external use only
                              Sterile until opened
                              Use with care to avoid contamination during use
                              Stored at room temperature
                              Date of sterilisation:
                              Expiry date: 4 week after opening (C) or 2 weeks after sterilisation (B)
                              BN:

                              Name of patient:                                          Date of dispensing:

                              Keep out of Reach of Children
                                         SCHOOL OF PHARMACEUTICAL SCIENCES,
                                                      USM, PENANG








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