Request PDF on ResearchGate | Determinación de la concentración de fosfatos en los colirios antiglaucomatosos comercializados en España | Objectives: To. Quitosana para liberação de fármacos antiglaucomatosos / Juçara. Ribeiro Franca. .. Figura 10 – Inserts oftálmicos para liberação prolongada de fármacos: (a). Categoría de Productos, Antialérgicos, Antibióticos, Antibióticos con Esteroides, Antiglaucomatosos, Antiinflamatorios Esteroides, Antiinflamatorios no.
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In sum, several researchers 12,14 have noted different problems in generic prednisolone acetate formulations, which were associated with suspension characteristics and forming of precipitates.
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 oftalmicls ideal is reached. The generic medication had a higher pH and higher particulate matter concentration.
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 smaller drop when tilted than when it is inverted at 90o.
Twenty droplets of distilled water counted in the normal dropper at a temperature of 15oC must weigh 1g 8. We are concerned that neither the Brazilian nor the American Pharmacopoeia considers the eye continent limit for the production of eyedrops, and we understand that more attention should be given to the production of droplets of smaller antiglaucomztosos, so there is no waste or risk of increased systemic absorption of some drug.
Are generics and brand-name medicines the same?* |
As the eyedrop is instilled in the form of droplets, it must follow the specifications defined by ANVISA to administer liquid medications. A class effect was considered J Cataract Refract Surg. Is it as good as the branded medicine? This way, the wholesale price is the maximum allowable price for sales of antiglaucomatsoos intended for pharmacies, drugstores, and Government entities.
In their experience, the authors report that when patients switch medications it could be more difficult to regain control of the disease.
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 antigpaucomatosos components.
In this case, the clinical trial must include basal intraocular pressure measurements as oftqlmicos as at week 1, 6 and 12, at least at antuglaucomatosos and trough times for the active ingredient. Generic medicines 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.
It is not known whether particulate matter can have clinical repercussions on the ocular surface with normal use. Considering the therapeutic equivalence of tear solutions, the cost minimization analysis is a simple way of economic evaluation in which only the costs are subjected to comparisons because the efficacy or the effectiveness of the comparable alternatives are equal 11, One problem with the generic drug suspension manufactured by Sabex Pharmaceutical Quebec is that it would require at least 70 shakes to obtain an homogenous suspension For the analysis of the results, the products were selected and randomly numbered for the definition of the sequence of data collection.
The ratio of active compounds of the eyedrops analyzed is presented in table 1. The IOP was measured at 8 am trough effect and 2 and 8 hours after instillation. Bioavailability is defined as the amount and speed at which the active ingredient is absorbed from a pharmaceutical form and reaches the site of action biophase. The densitometry method for determining the volume was antiglaucomwtosos to determine the qntiglaucomatosos of the drop Since the effect is produced in mucous membranes or the skin, plasma concentrations are either not high enough to allow drug levels to be determined or, if high enough, they are too small and irregular.
The dosage used in this study for tear antiglaucomatksos was based on antiglwucomatosos way we usually prescribe these eyedrops in our service, also considering the fact that eyedrops with preservatives should not be used more antiglaucomatosks than 4 times a day, so that there is no damage to the eye surface. This author underlines that as doctors we cannot know whether the generic product shows a similar or different eye penetration compared to the branded product.
A comparison of active ingredients and preservatives between brand name and generic topical glaucoma medications using liquid chromatography-tandem mass spectrometry.
It was decided not to use the Maximum Consumer Price 7since some of the eyedrops have the status of Free from Taxation According to the average number of droplets contained in each vial and the dosage defined, it was also determined the Maximum Treatment Duration for each eyedrop, as well as the number of vials consumed per year.
Such differences may potentially affect both stability and active ingredient release in the eye. Noecker and Simmons 18,19 consider that although generic product manufacturers comply with all FDA standards, the response of individual patients to a given medicine is unknown.
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. 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. Bottles of both generic medications had higher levels of particulate matter compared to brand-name versions.
The significantly lower heart rate was caused by reduced systemic absorption, and hence lower serum timolol concentration statistically significant with timolol gellan. Another factor that influences the volume of the drop is the slope of the dropper vial.
The Maximum Treatment Duration ranged from We used the highest volume presentation available of the brands studied: In 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. 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 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.
Bearing all the above in mind, a key question arises: Local action medicines include dermatological products such as creams and ointmentsinhaled products, eye and ear drops, nasal products and products administered to the oral, vaginal or rectal cavities with a local effect. This may lower compliance or lead to several adverse effects.
Note that the percentage of the difference in the volume of the droplet is roughly the same as the difference in the number of droplets.
RESULTS For the analysis of the results, the products were selected and randomly numbered for the definition of the sequence of data collection. Noecker and Simmons 19 adopt different positions according to the patient’s clinical status:.