Page 13 - FAR 222 Laboratory Manual V2 2019
P. 13

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


                  Option 2: Sorensen’s phosphate vehicle via White Vincent
                  Calculation 1: The best
                                                 30 mL           V                    Weight NaCl
                   Pilocarpine HCl     1 %       0.3 g           0.3×111.1×0.24 = 8   8/(111.1x1)= 0.072
                   (0.5% pH 3.8-5.2)                             mL                   g
                   Benzalkonium        0.01 %    15 mL (0.02%    -
                   chloride                      stock)
                   Sorensen’s                    100 mL          100 mL               30 mL
                   isotonic vehicle
                   Sodium acid         NaH2PO4  40 mL            0.416 g              0.125 g
                   phosphate           2 H2O
                                       1.04
                                       %w/v or
                                       0.0667 M
                                       or mol/L
                                       (MW
                                       156)
                   Sodium phosphate    Na2HPO4  60 mL            1.434 g              0.43 g
                                       12 H2O
                                       2.39
                                       %w/v or
                                       0.0667 M
                                       (MW
                                       358.1)
                   Sodium chloride     NaCl      0.46 g          0.46 g               Amt needed = 0.46
                                                                                      – 0.072 =0.388 g
                   Distilled water     qs ad     30 mL
                                       100 mL

                                                                            30 mL
                   Pilocarpine HCl (0.5% pH 3.8-5.2)    1 %                 0.3 g
                   Benzalkonium chloride                0.01 %              15 mL (0.02% stock)
                   Sodium acid phosphate                NaH2PO4 2 H2O        0.125 g
                                                        1.04 %w/v or
                                                        0.0667 M or mol/L
                                                        (MW 156)
                   Sodium phosphate                     Na2HPO4 12 H2O      0.43 g
                                                        2.39 %w/v or
                                                        0.0667 M (MW
                                                        358.1)
                   Sodium chloride                      NaCl                0.388 g
                   Distilled water                      qs ad 100 mL        30 mL


                  OR

                  Calculation 2: The limitation to this approach is that the final formulation pH may be different than the
                  desired pH. The final pH will depend on the two pHs and buffer capacities of the Sorensen's buffer and the
                  aqueous drug solution.

                                                 30 mL           V
                   Pilocarpine HCl     1 %       0.3 g           0.3×111.1×0.24 = 8
                   (0.5% pH 3.8-5.2)                             mL
                   Benzalkonium        0.01 %    15 mL (0.02%    -
                   chloride                      stock)
                                                 SPV needed =   30 – 8 = 22 mL
                   Sorensen’s                    100 mL          100 mL               22 mL needed
                   isotonic vehicle
                   Sodium acid         NaH2PO4  40 mL            0.416 g              0.092 g
                   phosphate           2 H2O

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