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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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To avoid violating patents, generics manufacturers intentionally change preservatives or the pH, although they never really know for sure how the original product is manufactured. This way, the wholesale price is the maximum allowable price for sales of medicines intended for pharmacies, drugstores, and Government entities.

In face of the European Medicines Agency, why does the FDA require all active and inactive components of a generic ophthalmic medicine to be exactly the same as in the reference product? By raising the contact time, these agents reduce nasolacrimal absorption and improve systemic safety. Considering the dosage of 1 drop in each eye four times a day, for a total of 8 drops a day, the average cost of the drop, the monthly and the annual cost of the treatment were estimated according to the wholesale price, which is the highest price at which a laboratory or distributor of medicines can sell their product in the Brazilian market.

Seventy-seven patients were studied and the primary efficacy endpoint was the mean IOP decrease, whereas the second efficacy endpoint was the percentage of patients with IOP value below 21 mm Hg at the end of the study. These differences are statistically significant.

The origin of particulate matter is unknown and could result from contaminants, active ingredient precipitates or container material. 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.

A comparison of active ingredients and preservatives between brand name and generic topical glaucoma medications using liquid chromatography-tandem mass spectrometry. Some surfactant preservatives also contribute to keeping lipophilic drugs in solution, such as prostaglandin analogues. As the eyedrop is instilled in the form of droplets, it must follow the specifications defined by ANVISA to administer liquid medications.


In the other brands, the droplet formed at 90o was bigger Graph 1. None of the eyedrop vials studied showed droplets ideal to the human eye, leading to product waste and increased cost to the manufacturer and the consumer. In both groups, all patients showed week IOP values lower than 21 oftalmics, i.

Are generics and brand-name medicines the same?* |

FDA criteria for determining clinical efficacy in these medicines vary according to the pharmacological group and are based on parameters or measures used to establish the efficacy of the innovator drug. If it causes discomfort or adverse effects, patients stop using the medicine and often do not report this until the following check up. 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.

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. 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.

The change from baseline in resting heart rate was J Cataract Refract Surg. In the ophthalmic practice, the main route of drug administration is made by eyedrops. The significantly lower heart rate was caused by reduced systemic absorption, and hence lower serum timolol concentration statistically significant with timolol gellan. This is not to say patients should not use generic drugs, but we must monitor the effects to ensure our patients are getting the cost savings they expect without sacrificing efficacy or creating side effects and tolerability issues.

On average, each medicine comprises five or six patents.


A total of 30 patients were included. Both safety and vision recovery time were similar in both groups. The densitometry method for determining the volume was used to determine the volume of the drop 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. 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.

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Laboratorios Grin

Original Articles Revista vol. However, a laboratory may apply for approval of a medicine that differs from the original, identifying and characterizing the differences and providing information to show that differences do not affect drug safety 2.

Generic versus brand-name North American topical glaucoma drops. Estacia P, Tognon T. All medications, both brand-name and generic, showed a reduction in active ingredient concentration and BAK when exposed to temperatures above those in the information leaflet. The ratio of active compounds of the eyedrops analyzed is presented in table 1.

Clinical differences between generic and brand-name anti-inflammatory ophthalmic medications. The main challenge in the development of generics of local or topical action medicines is that no bioavailability studies can be performed to compare plasma concentration profiles between reference and generic formulation drugs. Impact of administration angle on the cost of artificial tear solutions: There were no significant differences in the antiglaucomatoeos of conjunctival hyperaemia or of any other adverse effect.

Desai C, Rajadhyaksha V. 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. No statistically significant differences oftalmico observed between both medications at 8 am, nor 2 hours after administration.