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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Some surfactant preservatives also contribute to keeping lipophilic drugs in solution, such as prostaglandin analogues. The method and form of administration should be similar to the approved product.

At the end of the second period, there were no significant differences between both treatments. The drop volume ranged from The serum timolol concentrations were 0. The increased basal active ingredient concentration could be a strategy to compensate the known degradation of drugs over time to levels below their optimal dose, including at room temperature.

Bioavailability is defined as the amount and speed at which the active ingredient is absorbed from a pharmaceutical form and reaches the site antiglaucomatsos action biophase. A randomized, crossover, open label pilot study to evaluate the efficacy and safety of Xalatan in comparison with generic Latanoprost Latoprost in subjects with primary open angle glaucoma or ocular hypertension. Later, the mass of 1. For eye drops, antitlaucomatosos 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.

On occasions, adverse effects translate into objective signs, but sometimes they appear over time as vague systemic complaints.


Besides that, in relation to the vial tilt, we found out that there is significant variation in the droplet volume, and there is a concern by manufacturers on this fact, since the directions of 12 out of the 13 brands tested fail to inform the consumer the correct way of instilling the eyedrop.


Noecker and Simmons 19 adopt different positions according to the patient’s clinical status:. 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 in mind the following factors: Viscosity-modifying agents increase drug contact time with the ocular surface, thus improving absorption. However, note that the current legislation does not bring the definition of determination of the droplet volume anymore, nor sets specific regulations for the droplet volume of eyedrops.

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. Antiglaucomatoeos Ocul Pharmacol Ther.

However, 8 hours after instillation the IOP was This may lower compliance or lead to several adverse effects. In the other brands, the droplet formed at 90o was bigger Graph 1. 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, In their experience, the authors report that when patients switch medications it could be more difficult to regain control of the disease.

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In both groups, all patients showed week IOP values lower than 21 mmHg, i. Systemic effects, if any, should be considered as side effects.

Temperature affects active ingredient concentration in eye drops.

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. Table 3 presents the difference in volume between the application of eyedrop at 90 degrees and 45 degrees.


There were no significant differences in the incidence of conjunctival hyperaemia or of any other adverse effect. It is not known whether particulate matter can have clinical repercussions on the ocular surface with normal use. We used the highest volume presentation available of the brands studied: This is not to say patients should not use generic drugs, but we must monitor the effects to ensure our patients are oftslmicos the cost savings they expect without sacrificing efficacy or creating side effects and tolerability issues.

Mammo ZN et al. He concludes that concerns about generic medications will only disappear when comparative studies antiglaucomatsos original medications are promoted and conducted for efficacy, safety and patient comfort. The reason is that preservatives such as BAK prevent the pH from increasing beyond 6. To the typical, expectable question: Clinical differences between generic and brand-name anti-inflammatory ophthalmic medications. The mean number of drops in each bottle was determined and ofralmicos pharmacoeconomic evaluation of the drops was made.

On average, each medicine comprises five or six patents. 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.