A General Overview On: Dentifrices
FILLING OF DENTRIFRICES IN TUBES:
The working process of a tube filling and closing machine can be divided into four main groups
-Handling of tubes
-Filling of Tubes
-Tubes closing and sealing
IN PROCESS EVALUTION AND STABILITY STUDIES:
While the formula is being validated, experimental paste should be evaluated to assure that they meet the pre established characteristics. Samples in tubes should be placed under stability testing at various temperatures, not only to ensure the stability of the formulation but also to assure compatibility with the tubes choose for marketing of the product.
Stability is the ability of toothpaste to retain its important characteristics essentially unchanged throughout its expected shelf life. test must access the physical stability of the paste as well as the chemical stability of its ingredients . in the case of therapeutic (medicated ) toothpaste , which are considered drugs , the stability of the active ingredients must be established and the reflected in the expiration data on the packages . stability evaluation must be conducted in conjunction with the packages development . final stability tests should always be performed on product packaged in its commercial container. Since stability studies should reflect the storage conditions that may be encountered during the expected lifetime of the product, there fore the evaluation should be carried out at temperatures ranging from 0 to 50 degree Celsius over the shelf life of the product. Insight into long term stability can often be attained through the use of accelerated stability studies during which increased temperatures may simulate the behavior of the product over along period in a relatively short studies a stability protocol may consist of the following schedule
-select the sample product
-perform the test for physical properties
-analyzed for chemical test
-weigh them store them at 5, 35, 45 degree centigrade and room temperature
-Samples are withdrawn at intervals and re-evaluated. Recommended evaluation intervals are 1 week, 1 month, 3 month and 6 months at elevated and reduced temperatures studies for 1, 2 and 3 years.
-In addition, samples should pass three cycles of freezer, oven without separation or major changes in specifications. Initial expiration dates for drugs containing toothpastes may be based on accelerated test data, but should be modified as real time data becomes available. Paste that still remain their original specifications after three months at 45 degree Celsius may carry an estimated expiration date of 2 year after manufacture.
Stability of Gels
The formulation and manufacture of a gel system is not complete without an evaluation of the stability of that system. The chemical integrity of dispersed active ingredients must be assured over the shelf –life of the product.
Types of unstable gels may vary from gels that “set up” during storage and can no longer be expressed from a tube.
-“gels that undergo a separation of phases, either of the liquid(as in syneresis) or of the solid (as in particle sedimentation)
-gels” that suffer a progressive loss of viscosity o consistency, changing from semisolid to viscous liquid.
Indian standard comprise of specification for tooth powder, this standard prescribes the requirements and the method of sampling and test for toothpowders. As per this standard, toothpowder shall be smooth, uniform, free flowing fine powders, free from hard abrasive materials. The other requirement as per this standard are determination of fineness, moisture and volatile matter, pH of 10% aqueous suspension, foaming power, presence of lead, arsenic and hard and sharp edged abrasive particles.
Some years ago semisolid pastes (with viscosity) were sold in inverted polyethylene bottles. These had limited success and were followed by pressurized aerosols containers producing products called “Dental foams” dispensing paste through a dip tube and foam-style valve. These pastes were pressurized with nitrogen. But they failed in the market owing to several reasons. One of it was that as the paste was dispensed the remaining paste in the container tended to cavitate, eventually discharging the nitrogen, inactivating the container and wasting the balance of product. Accidental misuse caused loss of the nitrogen propellant and was responsible for many failures.
The snapshot of global oral health outlined in this article represents a ‘good news/bad news’ scenario. Overall, many adults are keeping their teeth longer, but retaining ones’ dentition longer translates to greater oral health challenges, such as plaque, calculus, and stain control. The development of new advanced all-in-one dentifrices, such as this advanced stannous-containing sodium fluoride formulation, represent a welcome supplement to patient oral care routines. A dentifrice serves as a logical delivery vehicle for therapeutic antimicrobials, plaque-removing surfactants, caries-fighting fluoride, and esthetic-enhancing ingredients, all in a single, accessible medium.
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