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As defined by regulatory standards, pharmaceutical equivalents require generic drug products to have identical dosage forms and chemically identical active pharmaceutical ingredients (APIs). They must adhere to compendial or applicable standards for potency, content uniformity, disintegration times, and dissolution rates. In the case of modified-release dosage forms, variations in drug content are permissible as long as the delivered amount remains consistent with the innovator drug product.
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Drug delivery methods like oral inhalation, nasal sprays, transdermal patches, eye drops, intravitreal injection,  and rectal administration provide localized effects with reduced toxicity.
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Pediatric patient dosages diverge from adults due to disparities in body surface area, total body water, and extracellular fluid per kilogram of body weight. The dosing regimen considers the variations in pharmacokinetics and pharmacology across distinct age groups, encompassing preterm newborns, infants, young children, older children, and adolescents. Calculation of pediatric patient doses is predicated on determining body surface area, which exhibits a superior correlation with the child's...
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Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
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Price Differences Between Otic and Ophthalmic Drops.

Chris Valentini1, Jiahui Lin, Justin S Golub

  • 1Department of Otolaryngology-Head & Neck Surgery, Columbia University Irving Medical Center, New York, New York.

Otology & Neurotology : Official Publication of the American Otological Society, American Neurotology Society [And] European Academy of Otology and Neurotology
|December 22, 2020
PubMed
Summary
This summary is machine-generated.

Ophthalmic drops are a cheaper alternative to otic drops, offering significant cost savings for patients. When appropriate, using ophthalmic formulations can reduce healthcare expenses.

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Area of Science:

  • Otolaryngology
  • Pharmacology
  • Health Economics

Background:

  • Otic drops are frequently prescribed in otolaryngology.
  • Some otic formulations are prohibitively expensive for patients.
  • Ophthalmic drops are sometimes substituted to reduce patient costs.

Purpose of the Study:

  • To determine the cost difference between otic and ophthalmic drops.
  • To evaluate the economic viability of using ophthalmic drops in otologic care.

Main Methods:

  • Telephone surveys of 83 pharmacies across three major US cities (New York City, Chicago, Portland).
  • Evaluation of pricing for common otic and ophthalmic formulations over a 6-week period.
  • Comparison of per-milliliter costs for specific drug combinations, including ciprofloxacin/dexamethasone, neomycin/polymyxin B sulfates/hydrocortisone, acetic acid, and ofloxacin.

Main Results:

  • Significant price disparities were observed between otic and ophthalmic formulations.
  • Ofloxacin ophthalmic drops ($11.00/mL) were substantially cheaper than otic drops ($31.00/mL).
  • Ciprofloxacin/dexamethasone otic was the most expensive ($38.00/mL), while neomycin/polymyxin B sulfates/hydrocortisone otic was the least expensive antibiotic option ($11.60/mL).

Conclusions:

  • Clinically appropriate ophthalmic drops represent a more cost-effective alternative to otic drops.
  • The safety profile of ophthalmic drops supports their consideration for otologic use.
  • Healthcare providers can leverage these findings to reduce patient out-of-pocket expenses.