Compounding with Sarah

  Prostaglandin Analogues for Alopecia: Considerations for the use of Latanoprost or Bimatoprost By Sarah Taylor, PharmD Prostaglandin analogues such as bimatoprost or latanoprost have historically been used ophthalmically, where they are FDA approved for the use of elevated intraocular pressure. Bimatoprost 0.03% has also been approved for the management of hypotrichosis of the eyelashes. The mechanism of action is prostaglandin analogues interact with prostanoid receptors in the hair follicle. This is thought to stimulate resting follicles in the telogen phase and convert them to the anagen phase (associated with hair growth). 3 This same mechanism of action that increases eyelash growth is thought to be responsible for the growing data to support the use of prostaglandin analogues topically on the scalp for alopecia. Data Regarding Alopecia of the Scalp Latanoprost has been studied at a very wide range of concentrations. One double-blind placebo controlled study on topi...

  Interpreting USP <800> Table 2 Primary Engineering Controls By Bryan Prince USP <800> is a relatively short document but packed with so much detail, requiring quite a bit of technical thinking and explanation, especially as it relates to the subject of engineering controls.   Pharmacists are not engineers, so one of the first questions is, how do I interpret Table 2. Engineering Controls for Nonsterile HD Compounding ? First, let’s dissect the two categories of engineering controls listed in Table 2.   The “C-PEC” is the containment primary engineering control, which is another name for a “powder hood”, also called a containment ventilated enclosure (CVE).   The table also lists other types of primary engineering controls, but for the sake of this discussion we will only focus on the most common type of hood found in a nonsterile compounding pharmacy.   The C-PEC will have either one single HEPA filter (see Figure-1) or two HEPA filters, ...

  Excipients for Hard-shell Capsules: Why Cellulose is Not Enough By Hudson Polonini,  BPharm MSc PhD Excipients are essential ingredients for a solid oral dosage form’s good performance, ensuring correct bioavailability, solubility, stability and dose accuracy. Therefore, choosing the right excipient is paramount for the adequate clinical performance of a robust dosage form. This choice needs to be based on technical parameters of both the active pharmaceutical ingredient (API) and the functionality of the dosage form itself – therefore science needs to be on the backbone of such process. As an example of the importance of the excipient’s role on the dosage form performance, we can consider the case of an intoxication that occurred in Australia in the late 1960s: epileptic patients who were taking phenytoin capsules experienced intoxications due to the replacement of the diluent. Calcium sulphate was changed to lactose, and this led to an increase of the mean serum conc...

  Regulatory Update – Clarification on the FDA’s Position on Compounding with Beta-Lactam Antibiotics   Why are compounders looking to compound amoxicillin? Amoxicillin (a beta-lactam antibiotic) for oral suspension is currently on acute shortage. A comprehensive list of products on shortage can be found at the FDA’s site here: FDA Drug Shortages .   Why the specific concern regarding beta-lactam antibiotics? Beta-lactam antibiotics are considered to represent a significant allergenic risk and cross-contamination between beta-lactam antibiotics and other drugs could potentially result in life-threatening allergenic reactions. The FDA has previously stated on their Insanitary Conditions at Compounding Facilities guidance for industry (GFI) that the processing of beta-lactams without complete and comprehensive separation from non-beta-lactam products is considered to be insanitary.   May 503a compounding pharmacies compound amoxicillin oral suspension d...

  Regulatory Update: USP <795> and <797> By Sarah Taylor, PharmD The road to publishing the revisions to USP General Chapters <795> and <797> has been a long one. Since their initial publication in June of 2019, USP has received several appeals on <795> and <797>. These appeals included potential harm to patients, unjustifiable burden on established businesses, and concerns regarding the proposed guidelines departing from scientific  consensus. 1   Though these reasons for appeal continue to be sources of concern, USP published revisions to <795> and <797> on November 1st, 2022, stating they are  “to be official 01-Nov-2023”. 2,3   What does this mean for my practice? Until November 1st, 2023, the current version of General Chapter <795>, which was last revised in 2014, will remain in effect. Similarly, the current version of General Chapter <797>, which was last revised in 2008, will al...

  Telogen Effluvium and COVID-19 By Sarah Taylor, PharmD There are a variety of different pathologies that can contribute to hair loss, including noncicatricial alopecia such as androgenic alopecia, alopecia areata, and telogen effluvium as well as cicatricial alopecia such as lichen planopilaris. 1 In this blog post, we’ll be focusing on telogen effluvium. Telogen effluvium may be acute or chronic. The acute form, the focus of this blog post, is defined as hair shedding that lasts for less than 6 months. Typically, this hair loss is precipitated by a stressor event that causes termination of the anagen (hair growth) phase and moves hair follicles into the telogen (resting) phase. The actual loss of hair occurs between two to three months after the trigger. 2 Potential triggers for telogen effluvium include certain medications (beta blockers, androgens, angiotensin-converting enzymes (ACE) inhibitors among others), physiologic stress, emotional stress, and even certain medi...

  Stabilization of Oxidation Prone Ingredients by Sarah Taylor, PharmD One of the constant struggles compounding pharmacists face is the stabilization of ingredients and formulations that are subject to change depending on a patient’s specific needs and conditions. Compatibility of different individual ingredients and combinations of ingredients at a wide potential range of concentrations can be difficult to ascertain without trial, error, and observation in the lab. In this newsletter, we will discuss a few active pharmaceutical ingredients (APIs) that often cause issues and review stabilizers that can be added that have demonstrated efficacy for reducing oxidation. Some ingredients commonly used for hyperpigmentation or other cosmetic conditions, such as aging skin are prone to oxidative degradation. Common examples include hydroquinone, kojic acid, and tretinoin. 1 The degradation of hydroquinone and kojic acid is associated with a darkening of color usually to a yellowish ...