Candy Base Report

EVALUATION TEST FOR LOZENGES

Quality Control (52)

Candy Base- For the candy base it is essential to check for corn syrup and sugar delivery gears; temperature, steam pressure, cooking speed, temperature and vacuum of candy based cooker.

MoistureAnalysis

Gravimetric method: Weigh 1g of sample and noted as its initial weight, it is then placed in a vacuum oven at 60-70oC for 12-16 hours. After specified intervals of time, once again weigh the sample and moisture content can be calculated using the following formula.

Moisture Content =Initial weight – final weight

Karl Fisher titration- A sample of the prepared lozenge is calculated to obtain 10-250mg of water which is then titrated with Karl Fischer reagent.

Azeotropic distillation method

Forming checks involves a checking of the rope diameter of the candy. Cooling checks is done on visual inspection to analyze any stress cracking due to rapid cooling, bubble formation, surface cracking and black spots.

Physical and Chemical Testing (53)

Hardness of the lozenges is determined by Pfizer or Monsanto hardness tester. Diameter and thickness of the lozenges are determined by using Verniercallipers. Friability of the prepared lozenges can be determined by Roche Friabilator operated at 25rpm for 4mins. Weight variation test is done on 20 lozenges, initially they are weighed and average.weight is determined. Individual weight is compared with the calculated average weight. Drug and the excipients interaction can be determined by FTIR. Invitrodrugrelease is carried out using USP II paddle type dissolution apparatus. Drug content is done by taking an appropriate number of lozenges being crushed and dissolved in a suitable solvent and the resultant absorbance of the solution is measured spectrophotometrically.

MICROBIOLOGICAL TEST FOR

Stability testing of Lozenges in the final packs can be done as either 25o C at 80%RH for 6-12months or 37o C at 80%RH for 3 months and or 25o C at 70%RH for 6-12 months etc.

PACKAGING OF LOZENGES (54, 55)

The lozenges are hygroscopic in nature hence a complex and multiple packaging is usually adopted. The individual unit is wrapped in polymeric moisture barrier material which are then placed in tight or moisture resistant glass, polyvinyl chloride or metal container which is then over wrapped by aluminum foil or cellophane paper.

STORAGE (50)

Lozenges areto be stored away from heat and out of reach of children. They should be protected in such a way that they must be devoid of extremes of humidity. Room temperature or refrigerator temperature is usually indicated depending upon the storage requirements of both the drug and the base on the