Drug products nasal spray

Gonadotropin-releasing hormone agonists (buserehn, nafarelin, and leuprolide), available as injectable drugs or nasal spray, suppress the production of ovarian androgens and are efficacious in acne. By reducing estrogen, they can produce menopausal symptoms (headache and bone loss). They have not been approved for treatment of acne. ... 

U.S. Food and Drug Administration (FDA) (2002, July), Nasal spray and inhalation solution, suspension, and spray drug products. Chemistry, manufacturing, and controls documentation, Guidance for industry. FDA, Washington, DC, 1—45. 

Inhalation drug products include inhalation aerosols (metered dose inhalers) inhalation solutions, suspensions, and sprays (administered via nebulizers) inhalation powders (dry powder inhalers) and nasal sprays. The CMC and preclinical considerations for inhalation drug products are unique in that these drug products are intended for respiratory tract-compromised patients. This is reflected in the level of concern given to the nature of the packaging components that may come in contact with the dosage form or the patient. 

It should be noted that many market names are used for all of the antiinflammatories listed in Table 2, depending on market liaisons, generic competition, derivatives such as esters, and the form of the drug product (e.g., topical, inhaler, nasal spray, etc.). For example, Schering s betamethasone 17,21-dipropionate is marketed as Diprosone, and Glaxo s betamethasone-17-valerate was marketed as Betnovate. 

Over-the-Counter Drugs (OTC) FDA-regulated products that do not require a physician s prescription. Some examples are aspirin, sunscreen, nasal spray and sunglasses. 

On February 17,2004, Nastech Pharmaceutical Company announced its filing of an ANDA for a salmon calcitonin nasal spray drug product for the treatment of postmenopausal osteoporosis. As with Fortical, Novartis s Miacalcin was cited as the reference listed drug however, Nastech chose to submit an ANDA via the 505(j)(l) route, rather than a 505(b)(2) application. 

Inhalation drug products, also referred to as orally inhaled and nasal drug products (OINDPs including inhalation aerosols and solutions, nasal aerosols and sprays), have a high likelihood of packaging component-dosage form interaction,and therefore have individual USFDA guidance documents. As an example, consider the metered dose inhaler (MDI), shown... 

Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products-Chemistry, Manufacturing, and Controls Documentation, Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CEDER) Rockville, MD, July 2002 1 5. 

Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products, May 1999 (Draft)... 

Nasal spray products contain therapeutically active ingredients (drug substances) dissolved or suspended in solutions or mixtures of excipients (e.g., preservatives, viscosity modifiers, emulsifiers, buffering agents) in non-pressurised dispensers that use metering spray pumps. (FDA 1999)... 

Many of the points raised in this section have been mentioned in the earlier sections on formulation and device. A Guidance for Industry document in draft form was issued by the FDA during 1999, Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products Chemistry, Manufacturing and Controls Documentation (FDA 1999). This document provides a plethora of information on issues the FDA will consider in submitted documentation supporting the approval of nasal products. There are over 1,600 lines in the document, and industry comments have been invited. Whilst the final document has yet to be issued, the draft is still an important reference. A brief review of the content of this draft document follows. 

The clinical efficacy of nasal and inhalation spray drug products is directly dependent on the design, reproducibility, and performance characteristics of the container closure system. 

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