By Sarfaraz K. Niazi
The 5th quantity within the sequence, this publication covers over the counter items, which come with formulations of goods labeled by way of the U.S. FDA below the OTC class. each one access starts off with a completely proven scaleable production formulation and a precis of producing technique. The ebook presents a close dialogue at the problems encountered in formulating and production OTC items. The part on regulatory and production information offers with the themes of cGMP practices for the OTC drug items, formulations of stable oral dosage varieties, oral suggestions and suspensions, validation of cleansing approach, as well as delivering fast tips about resolving the typical difficulties in formulating OTC medications.
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Additional resources for Handbook of Pharmaceutical Manufacturing Formulations Volume 5 of 6: Over-the-Counter Products
50 g QS to 1 L IV. HYDROXYPROPYL METHYL CELLULOSE/HYDROXYPROPYL CELLULOSE (KLUCEL®) COATING A. 50 QS Item 1 2 3 4 5 6 Bill of Materials Material Name Titanium dioxide Hydroxypropyl cellulose, NC Alcohol (200 proof), SD 3A Propylene glycol Hydroxypropyl methyl cellulose 2910 (15 cps) Methylene chloride MANUFACTURING DIRECTIONS Place the titanium dioxide and sufficient methylene chloride into suitably sized ball jars to cover the balls. Mill for not less than 16 hours. While mixing the alcohol, add and disperse the hydroxypropyl methyl cellulose, hydroxypropyl cellulose, and propylene glycol, followed by 250 mL of methylene chloride.
In one form, the culture is added to representative units of the lot to be sterilized or to a simulated product that offers no less resistance to sterilization than the product to be sterilized. The second form is used when the first form is not practical, as in the case of solids. In the second form, the culture is added to disks or strips of filter paper or metal, glass, or plastic beads. Data required to establish the choice of indicator include: • • • Surveys of the types and number of organisms in the product before sterilization Data on the resistance of the organism to the specific sterilization process Data used for selecting the most resistant organism and its form (spore or vegetative cell) © 2004 by CRC Press LLC • • 7 Studies of the stability and resistance of the selected organism to the specific sterilization process Studies on the recovery of the organism used to inoculate the product If a simulated product or surface similar to the solid product is used, the simulation or similarity must be validated.
Add the melted Carbowax to the mixture from the second step. Empty contents of ball jar mill to this mixture. Rinse the ball jar with acetone, and add rinsings. Add acetone to volumem and mix well. If necessary, strain solution through gauge before storage or use. B. Cherry Red In the formulation given above, use, FD&C Red Dye No. 800 g), FD&C Red Dye No. 40 g). C. Clear Delete dyes. D. Orange Use FD&C Yellow Dye No. 00 g) and FD&C Yellow Dye No. 00 g). 00 g QS to 1 L Appendix: Coating Solutions 325 X.