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A generic medicine is defined as a product having the same qualitative and quantitative composition in active ingredients, as well as the same pharmaceutical form, as the reference medicine and whose bioequivalence has been shown by adequate bioavailability studies.
When patients ask about replacing a branded product with its generic counterpart, all we can honestly say as doctors is that the new generic medicine has not been studied, analysed or compared to the original medicine, and so we cannot know whether it will act in a similar way — in other words, whether both medicines are equally effective. Basically, the FDA criterion for determining therapeutic equivalence is formulation equivalence.
Bearing in mind that an active ingredient is in balance between systemic circulation and the site of action, it is assumed that drug values in blood represent drug bioavailability. The average number of drops per vial was determined by dividing the volume announced by the manufacturer for the presentation of bigger content by the average volume of each drop, also obtaining the difference of the number of droplets formed per vial according to the tilt.
No differences in excipient composition are accepted.
Therefore, the time between follow-up visits should be reduced when patients switch to generics to ensure that the new medicine is working adequately and the patient has no complaints. Therefore, we realized that the droplet volume of eyedrop is still considerably high, and that this leads to a waste of the product and increased cost to the manufacturer and the consumer.
Another factor that influences the volume of the drop is the slope of the dropper vial. Bearing all the above in mind, a key question arises: In general, patients try the medicine we prescribe. Bioequivalence is the comparison between the bioavailability of a medicine under study and the bioavailability of a reference drug.
Such differences may potentially affect both stability and active ingredient release in the eye. The 5th Edition of the Brazilian Pharmacopeia published in is the Official Pharmaceutical Code followed in Brazil, and sets the standards and specifications of pharmaceutical, medications and other products subject to sanitary surveillance. To determine the mean drop volume produced by artificial tear solutions in different inclination angles and to determine the mean cost of the treatment.
The US Food and Drugs Administration FDA 1 requires that study medicines contain the same active and inactive ingredients at the same concentration as the reference product.
According to the shape of the tip of the stopper and the surface tension of the liquid, there is a tendency of each vial producing a bigger or antiglaucomatosow drop when tilted than when it is inverted at 90o.
Oftalmicps droplets of distilled water oftalmicks in the normal dropper at a temperature of 15oC must weigh 1g 8. In turn, they can modify the ability of a given active ingredient to remain in solution and stabilize interaction with the tear film, affecting tolerance. For instance, in ocular hypotensive medicines, equivalence is determined if the difference measured between both products is lower than 1.
As reported by the authors in the abstract, the study showed that the new product is non-inferior to antiglaucomagosos original product. The densitometry method for determining the volume was used to determine the volume of the drop Some surfactant preservatives also contribute to keeping lipophilic drugs in solution, such as prostaglandin analogues.
Dosage variability of topical ocular hypotensive products: In their experience, the authors report that when patients switch medications it could be more difficult to regain control of the disease.
Farmacos Oftalmologicos by Naldo Jimenez on Prezi
Each vial of eyedrops was lightly pressed until a drop fell off from a height of 5. The change from baseline in peak heart rate was For the analysis of the results, the products were selected and randomly numbered for the definition of the sequence of data collection. Table 3 presents the difference in volume between the application of eyedrop at 90 degrees and 45 degrees.
Desai C, Rajadhyaksha V. The concept of pharmacoeconomics is growing nowadays, and concerns the application of the principles of economics to the study of medications and health practices, aiming at the optimization in the use of financial resources without prejudice to quality and treatment outcomes Revista Brasileira de Oftalmologia.
For eye drops, nasal sprays and cutaneous solutions, bioequivalence is accepted if the drug is in the same solution aqueous or oily and contains the same active ingredient concentration as the reference product. Leia na Palavra do Presidente.
Are generics and brand-name medicines the same?*
While some patients tolerate eye drop switches with minimal discomfort, others are extremely sensitive and can report small changes associated with preservatives, pH, tonicity or other components. The ratio of active compounds of the eyedrops analyzed is presented in table 1. In both groups, all patients showed week IOP values lower than 21 mmHg, i.
The timolol-dorzolamide combination in both brand-name and generic medications is relatively resistant to degradation. Further studies should be conducted with other classes of eyedrops, and we must worry each time more about the droplet volume of eyedrop, so that an ideal is reached.
The antiglaucomaatosos were open at the time of test, and the weighing of drops atniglaucomatosos held by the same researcher, being filed the batch of each vial. Finally, some authors consider that if the main and only advantage of generic medicines is their cost, cost analyses should not compare just the medicine price, but they should also bear pftalmicos mind the following factors: Concentraciones de brimonidina en humor acuoso en el tiempo.
The origin of particulate matter is unknown and could result from contaminants, active ingredient precipitates or container material. The reason is that preservatives such as BAK prevent the pH from increasing beyond 6.
Noecker and Simmons 19 state that “There is no doubt we are moving toward a totally generic world, and as our antiglaucomatossos adapt to different medicines, we must monitor efficacy and safety vigilantly.
In this case, the clinical trial must include basal intraocular pressure measurements as well as at week 1, 6 and 12, at least at peak and trough times for the active ingredient.
The importance of excipients Tabla 1. A total of 30 patients were included. The significantly lower heart rate was caused by reduced systemic absorption, and hence lower serum timolol concentration statistically significant with timolol gellan.
We used the highest volume presentation available of the brands studied: He concludes that concerns about generic medications will only disappear when comparative studies with original medications are promoted and conducted for efficacy, safety and patient comfort.
Original Articles Revista vol. Antiglaucomatsos the absence of comparative studies between the brand-name and the generic medication, FDA classified the generic formulation of the timolol maleate gel forming solution Falcon Laboratories as ABalthough the products are formulated with different slow-release gel vehicles. None of the eyedrop vials studied showed droplets ideal to the human eye, leading to product oftalmicod and increased cost to the manufacturer and the consumer.
This way, the wholesale price is the maximum allowable price for sales of medicines intended for pharmacies, drugstores, antiglaucmatosos Government entities. Table 2 presents the results of the mass of 10 drops and 1 milliliter drop volume, the volume of the droplet formed, the volume of the largest presentation found in market for each brand, and the wholesale price of the eyedrops analyzed under different tilt angles of the bottle during application.