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 determine the mean drop volume produced by artificial tear solutions in different inclination angles and to determine the mean cost of the treatment. The mean number of drops in each bottle was determined and a pharmacoeconomic evaluation of the drops was made. The drop volume ranged from None of the collyria studied presented ideal drops for human eyes, leading to a waste of the product and higher cost for the manufacturer and the consumer.
In the ophthalmic practice, the main route of drug administration is made by eyedrops.
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The official medical eyedropper, according to the American Pharmacopoeia, presents an outter diameter of 3 mm and dispenses 20 drops of distilled water per mL at a temperature of 25oC by positioning the eyedropper perpendicular to the person that will receive the drop 1.
Thus, a drop of larger volume applied to a human eye will have its excess overflowed through the face and drained by the lacrimal pathways 2. Another factor that influences the volume of the drop is the slope of the dropper vial.
According to the shape of the tip of the stopper and the surface tension of the liquid, there is oftalmicks tendency of each vial producing a bigger or smaller drop when tilted than when it is inverted at 90o.
Three original vials were tested from 13 brands of tear solution: We used the highest volume presentation available of the brands studied: The ratio of active compounds of the eyedrops analyzed is presented in table 1. The densitometry method for determining the volume was used to determine the volume of the drop The eyedrops were open at the time antglaucomatosos test, and the weighing of drops was held by the same researcher, being filed the batch of each vial.
.: Portal da SBO – Sociedade Brasileira de Oftalmologia :.
Each vial of eyedrops was lightly pressed until a drop fell off from a height of 5. For proper tilt, antiglaucojatosos protractor was used as a guide in a reference plane, and in relation to the vial base 3,6.
Later, the mass of 1. This way, the average volume of each droplet was determined by the ratio between the mass of 1. Antiglacuomatosos average number of droplets contained in each vial was also determined, taking into account the average volume of each drop and the total volume of the vial as advertised by the manufacturer on the product label Considering the dosage of 1 drop in each eye four times a day, for a total of 8 drops oftakmicos 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 oftalmicox laboratory or distributor of medicines can sell their product in the Brazilian market.
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This way, the wholesale price is the maximum allowable price for sales of medicines intended for pharmacies, drugstores, and Government entities. 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.
For the analysis of the results, the products were selected and randomly numbered for the definition of the sequence of data collection. 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 qntiglaucomatosos largest presentation found in market for each brand, and the wholesale price of the eyedrops antiglaucomatooss under different tilt angles of the bottle during application.
Table 3 presents otalmicos difference in volume between the application of eyedrop at 90 degrees and 45 degrees. 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.
The results show that there is a trickle pattern between the different vials studied, since the volume of the droplets ranged from In the other brands, the droplet formed at 90o was bigger Graph 1.
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Note that the percentage of the difference in the volume of the droplet is roughly the antiglaucomxtosos as the difference in the number of droplets. However, with the sign reversed, the bigger the drop the smaller number of droplets contained in vials will be, increasing the final cost to the consumer. Table 4 presents the average cost per droplet of each eyedrop and the difference in price between the two different tilts, as well as monthly antiglaucomaotsos annual average cost for a treatment defined as 1 droplet in each eye four times a day, with a total of 8 droplets per day.
The Maximum Treatment Duration ranged from 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.
In the previous edition, the Brazilian Pharmacopeia defined that any measurement tool antiglaucomafosos administer liquid medicines must meet specific volumetric standards: Twenty droplets of distilled water counted in the normal dropper at a temperature of 15oC must weigh 1g 8.
As the eyedrop is instilled antiglaucmoatosos the form of droplets, it must follow the specifications defined by ANVISA to administer liquid medications. 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. antiglucomatosos
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.
The dosage used in this study for tear solutions was based on the way we usually prescribe these eyedrops in our service, also considering the fact that eyedrops with preservatives should not be used more frequently than 4 times a day, so that there is no damage to the eye surface.
However, it is worth considering that each product has its particularities and individual characteristics that may lead to a need for greater or lesser frequency of application. 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 volume, so there is no waste or risk of increased systemic absorption of some drug.
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 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, 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.
Once the adjustment of the stopper to calibrate smaller droplets is a costly process, an immediate action to minimize the cost would be properly guide the consumers in a descriptive and illustrative way in the directions of which would be the best way of applying each eyedrop.
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. 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.
Original Articles Revista vol. RESULTS For the analysis of the results, the products were selected and randomly numbered for the definition of the sequence of data collection. The United States Pharmacopeial Convention; Estacia P, Tognon T.
Dosage variability of topical ocular hypotensive products: Impact of administration angle on the cost of artificial tear solutions: J Ocul Pharmacol Ther. Revista Brasileira de Oftalmologia. Leia antiglaucojatosos Palavra do Presidente.