Bot Detector
IJPC Seal
Download FREE Sample Issue or Article
LEARN MORE
Subscribe Today
A subscription to IJPC provides on-line access to full-text, full-color, printable PDF copies of your subscribed issues, individual articles, and purchased archives.

Development of Stable and Simple Finasteride 333-μg/mL Suspensions that Minimize Occupational Exposure

Author(s):  Ma Nathan, Perks William, Law Shirley, Iazzetta John, Walker Scott

Issue:  Nov/Dec 2020 - Volume 24, Number 6
View All Articles in Issue

Page(s):  519-527

Development of Stable and Simple Finasteride 333-μg/mL Suspensions that Minimize Occupational Exposure Page 1
Development of Stable and Simple Finasteride 333-μg/mL Suspensions that Minimize Occupational Exposure Page 2
Development of Stable and Simple Finasteride 333-μg/mL Suspensions that Minimize Occupational Exposure Page 3
Development of Stable and Simple Finasteride 333-μg/mL Suspensions that Minimize Occupational Exposure Page 4
Development of Stable and Simple Finasteride 333-μg/mL Suspensions that Minimize Occupational Exposure Page 5
Development of Stable and Simple Finasteride 333-μg/mL Suspensions that Minimize Occupational Exposure Page 6
Development of Stable and Simple Finasteride 333-μg/mL Suspensions that Minimize Occupational Exposure Page 7
Development of Stable and Simple Finasteride 333-μg/mL Suspensions that Minimize Occupational Exposure Page 8
Development of Stable and Simple Finasteride 333-μg/mL Suspensions that Minimize Occupational Exposure Page 9

Download in electronic PDF format for $75

Abstract:  Finasteride is not commercially available in a liquid format, which stimulated the development of a stable and simple finasteride suspension formulation. The objectives of this work were to develop and test a finasteride suspension for 1) simplicity to compound, 2) pharmaceutical acceptability, 3) stability, and 4) potential for occupational exposure. The stability of commercial 5-mg finasteride tablets (50 mg/150 mL) was evaluated in water, Oral Mix, and OralMix SF in amber polyethylene terephthalate bottles at 25°C or 4°C. Additional stability studies were carried out using sugar-free Finasteride Powder USP in amber polyethylene terephthalate bottles and tablets in water in polypropylene oral syringes. On study days 0, 1, 3, 7, 14, 28, 38, 49, 63, and 90, the finasteride concentration was determined using a validated stability-indicating liquid chromatographic method. The potential occupational airborne exposure was evaluated by attempting to measure finasteride in 1000 liters of room air following shaking and nebulization. Finasteride suspension/dispersion formulations were prepared in water, Oral Mix, and Oral Mix SF from tablets and pure powder. All formulations retained more than 94.3% of the initial finasteride concentration, with 95% confidence, when stored for up to 90 days at room temperature or 4°C. Simulations of occupational exposure failed to demonstrate the presence of finasteride in room air following attempts to nebulize finasteride mixtures. We conclude that 333-µg/mL suspension/dispersions of finasteride in water or Oral Mix products will have more than 94.3% of the initial finasteride concentration remaining after 90 days, regardless of the formulation, container, or storage temperature. Although we could not detect finasteride in room air, given the analytical limits of the study, we estimate that exposure would unlikely exceed 3.6-µg/1000 liters of room air. Nevertheless, since current regulations are based on “no safe limit,” use of primary engineering controls and personal protective equipment as appropriate is recommended.

Related Keywords: Nathan Ma, RPh, HBSc, PharmD, ACPR, MSc, William Perks, RPh, BSc (Pharm), EMBA, Shirley Law, Dip Pharm Tech, John Iazzetta, PharmD, Scott Walker, MScPhm, finasteride, oral suspension, hazardous drug, occupational exposure, workplace safety, stability, vaporization, aerosolization, dispersion, nebulization

Related Categories: ENVIRONMENTAL , STABILITIES, COMPATIBILITIES, DOSAGE FORMS/DRUG CARRIERS, PROFESSIONAL ISSUES

Printer-Friendly Version



Related Articles from IJPC
Title/Author
(Click for Abstract / Details / Purchase)
Issue/​Page
View/Buy
Development of Stable and Simple Finasteride 333-μg/mL Suspensions that Minimize Occupational Exposure
Ma Nathan
, Perks William, Law Shirley, Iazzetta John, Walker Scott
Nov/Dec 2020
Pg. 519-527

Chemical Stability of Epinephrine 10 mcg/mL Diluted in 0.9% Sodium Chloride and Stored in Polypropylene Syringes at 4 degrees C and 25 degrees C
Hook Roxanne
, Neault Ashleigh, Scharrer Devan, Law Shirley, Walker Scott E, Ma Nathan H, Riss Vera
Jul/Aug 2023
Pg. 347-351

Stability of Extemporaneously Compounded Nadolol 10-mg/mL Suspension in Oral Mix in Glass and Plastic Bottles and Plastic Syringes
Walsh Andrea
, Ziegler Blake, Lingertat-Walsh Karen, Law Shirley, Walker Scott E
Mar/Apr 2021
Pg. 163-168

Stability Studies of Fludrocortisone Acetate Capsules and Fludrocortisone Acetate Titrated Powders (Powder Triturates)
Brandin Thibaut
, Wasilewski Maya, Panuccio Camille, Bouguergour Cyrielle, Primas Nicolas, Lamy Edouard, Jean Christophe, Bertault-Peres Pierre, Rathelot Pascal, Curti Christophe, Vanelle Patrice
Mar/Apr 2022
Pg. 150-154

Stability of Venlafaxine Immediate-Release Suspensions
Donnelly Ronald F
, Wong Keith, Goddard Rob, Johanson Christel
Jan/Feb 2011
Pg. 81-84

Incorporating Quality Assurance in Pharmaceutical Compounding-related Courses in the PharmD Curricula
Hossain Mohammad Faisal
, Levesque Dan, Frye John, Rashid Mamoon
Jul/Aug 2020
Pg. 322-326

Comparison of Rheological and Sedimentation Behavior of Commercially Available Suspending Vehicles for Oral Pharmaceutical Preparations
Visser J Carolina
, ten Seldam Inge E J, van der Linden Isabella J, Hinrichs Wouter L J, Veenendaal Reinier F H, Dijkers Eli C F, Woerdenbag Herman J
May/Jun 2018
Pg. 247-251

Compounding for Skin Care: An Interview with John Hollis, RPh
Vail Jane
Mar/Apr 2002
Pg. 85-86

Finding the Right Balance: A Nationwide Study of Student Pharmacist Exposure to and Perceptions of Nonsterile Compounding
Fredrickson Mary E
, Belcher Faith G, Del Vecchio Kamryn N, Galleher Miranda N, Jugo Leila S, Gothard M David, Pallotta Raneem H, Pallotta Victor A Jr
May/Jun 2022
Pg. 242-247

Stability Assessment of Repackaged Bevacizumab for Intravitreal Administration
Pereboom Marieke
, Becker Matthijs L, Amenchar Mostapha, Verweij Sjoerd L, van der Hoeven Ruud TM, Mulder Inge J
Jan/Feb 2015
Pg. 70-72

Stability of Extemporaneously Prepared Hydroxycarbamide Oral Suspensions
Kabiche Djamila
, Balde Issa-Bella, Majoul Elyes, Kabiche Sofiane, Bourguignon Elodie, Fontan Jean-Eudes, Cisternino Salvatore, Schlatter Joel
Mar/Apr 2017
Pg. 160-163

Pharmacokinetics of Sumatriptan 25-mg Oral Tablet Versus 25-mg Extemporaneous Suppository in Healthy Volunteers
Desai Hiral D
, Shirley Kara L, Penzak Scott R, Strom J Grady, Hon Yeun Yi, Spratlin Vicky, Jann Michael W
Nov/Dec 2003
Pg. 481-484

Development and Validation of a Stability-indicating High-performance Liquid Chromatographic Method for Quantification of Progesterone in Compounded Glycerinated Gelatin Troches
Burrows Anna C
, Yellepeddi Venkata Kashyap, Snyder Spencer, Wakefield Meagan, Jackson David, Huynh Johnny, Nguyen Khoa, Sayre Casey L
Jul/Aug 2019
Pg. 340-350

Compounding for Diabetic Patients:An Interview with Paul Lofholm, PharmD
Allen Loyd V Jr
Nov/Dec 1997
Pg. 381-385

PreScription: The International Academy of Compounding Pharmacists Remembers Evelyn Timmons, RPh, FIACP, and George Roentsch, RPh, FIACP
Karolchyk Scott
Jan/Feb 2012
Pg. 4

View Sample
Development and Validation of an Inexpensive, Simple, and Rapid Technique for Measuring the Accuracy of Extemporaneously Compounded Pharmaceuticals
Meek Claudia
, Rothardt Andrew, Evans Jason, Thurman Rosanne, Ashworth Lisa, Leff Richard
Jul/Aug 2015
Pg. 340-343

Antineoplastic Drug Contamination on the Outside of Prepared Infusion Bags
Breukels Oscar
, van der Gronde Toon, Simons-Sanders Kathleen, Crul Mirjam
Jul/Aug 2018
Pg. 345-349

PreScription: Permissible Exposure Limits and United States Pharmacopeia Chapter <800>
Allen Loyd V Jr
Sep/Oct 2021
Pg. 356

Pathophysiology and Management of Onychomycosis and Novel Approaches for Effective Transdermal Applications
Dharmian Jose Prakash
, Sathiyaseelan Iraniammal, Renganathan Akshaya, Mubees Alamaan Mohamed, Naser Mohammed Yasin Abdul, Ramkrishnan Prakash, Arumugam Somasundaram
Nov/Dec 2023
Pg. 494-502

Stability of Compounded Diltiazem Hydrochloride in Cream, Ointment, and Gel Formulations for Topical Use
Teimouri Arezou
, Yeung Pollen, Agu Remigius U
Nov/Dec 2020
Pg. 482-490

Return to Top