International journal of pharmaceutical compounding最新文献

Personalized medicine has become a crucial approach in dermatology, particularly in the treatment of androgenetic alopecia (AGA) and other scalp conditions. This study evaluates the compatibility of the TrichoConcept™ line - comprising TrichoSol™, TrichoFoam™, TrichoWash™, and TrichoCond™ - as vehicles for active pharmaceutical ingredients (APIs) commonly used in alopecia treatment, including biotin, caffeine, finasteride, fluocinolone, ketoconazole, melatonin, minoxidil, niacinamide, prostaquinon, pyridoxine, and tretinoin. High-performance liquid chromatography (HPLC) and forced degradation studies were conducted to assess physicochemical stability. The results indicate that F1 (biotin 0.5%, caffeine 2.0% and niacinamide 2.0% in TrichoCond™) and F3 (caffeine 2.0%, melatonin 2.0% and pyridoxine 0.5% in TrichoCond™) remained stable for 180 days, while F2 (finasteride 0.1%, minoxidil 1.0% and tretinoin 0.01% in TrichoSol™) was stable for 14 days. Additionally, F4 (fluocinolone 0.01% and ketoconazole 2.0% in TrichoWash™) and F5 (minoxidil 7.0%, tretinoin 0.02% in TrichoCond™) showed stability for 150 days. F6 and F7 (prostaquinon 3.0% in TrichoSol™ and TrichoFoam™, respectively) showed stability for 180 days. These findings support the use of the TrichoConcept™ line as a reliable vehicle for customized hair loss treatments, enhancing both therapeutic outcomes and patient adherence.

While the advertising of FDA approved prescription drugs is highly regulated and clear guidelines are abundant, the limitations on allowable advertising for compounded medications are oblique, confusing, and inconsistently enforced. As a result, many compounding pharmacies find themselves taking an overly conservative approach out of fear of enforcement actions, while others step too boldly, seeking forgiveness rather than permission. This article explores both the historical reasons for the surprising level of ambiguity and uncertainty in the advertising of compounding pharmacies, as well as some helpful guidelines for developing compliant ads and appropriately assessing the risk of enforcement actions.

On average, at least about 85-90% of compounded (magistral) medicinal products are prescribed by doctors in Hungary on an individual basis, outside the official National Formulary of compounded medicinal products (Formulae Normales or FoNo). Until now, the problem has been that no one has had a comprehensive understanding of the domestic non-FoNo compounded medicinal products, so the authorities have not been able to issue detailed regulations to address typical problems. However, from the database www.magisztralisvenyek.hu, available since 2020, the characteristics and typical errors of compounding can be well studied. In the absence of reforms, the field of compounded medicinal products in Hungary has become very outdated compared to some developed countries (especially Germany) and has entered a crisis. Doctors are prescribing a lot of compounded products of unproven efficacy, safety and stability. The Author gives an overview of the characteristics and problems of some groups of non-FoNo compounded preparations, describes the historical reasons for the current situation and proposes a reform of compounding.

In the article "Physical Compatibility of Cefiderocol with Selected Intravenous Drugs During Simulated Y-site Administration," [Reference: Int J Pharm Compd. 2021; 25 (1): 52-61.] Table 1, row 33 states that the challenge drug was "Total Parenteral Nutrition, Hospira (Lot 87-308-DK)." This challenge drug description should be corrected to "TPN Electrolytes, Hospira (Lot 87-308-DK).

Objectives: This study aimed to investigate the physicochemical stability of morphine hydrochloride and droperidol mixture stored in polypropylene syringes to prepare them in advance by a centralised intravenous additive service (CIVAS).

Methods: Five polypropylene syringes containing 2 mg/mL morphine hydrochloride and 0.083 mg/mL droperidol were stored in a light-protected environment at room temperature. The physical and chemical stability of solutions was periodically evaluated over a 50 days-period. The samples were visually and microscopically examined, the absorbance at three different wavelengths (350, 410, and 550 nm) and the pH were measured. An ultra-high performance liquid chromatography-photodiode array detection (UHPLC-PDA) method was developed and validated to determine the concentrations of these two drugs simultaneously.

Results: Over the course of the 50-days evaluation, no observable change in colour, particle or crystal formation was detected in any of the samples by visual and microscopic examinations. The pH and absorbance at only 350 nm exhibited a slight upward trend over time in all five syringes. Regarding the chemical stability, the lower limit of the one-side 95 percent prediction interval (LL95PI) remains above 90% of the initial mean concentration for the five syringes.

Conclusions: The pharmaceutical preparation of 2mg/mL morphine hydrochloride and 0.083 mg/mL droperidol in polypropylene syringes, stored in a light-protected environment at room temperature, displayed stability throughout the 50-days study period. It is noteworthy that even there were slight variations in pH and absorbance at 350 nm, these observations, to the best of our knowledge, do not contraindicate the preparation of this admixture in advance under aseptic conditions by a CIVAS. However, the compounding process must be validated for sterility, accuracy and reproducibility.

The pharmaceutical industry has been moving towards medications and tests that are not animal derived or have animal components for many years, for several reasons (e.g., diseases in animals, shortage of the animal or animal body part the substance is derived from). It can be a slow or fast process to move from an animal derived substance to producing a synthetic version depending on the substance and the public health need.

Hiring an outside sales representative for your compounding pharmacy-have you ever considered it? For many of us, it's been a game-changing move that expanded our each, grew revenue, and ultimately strengthened our businesses. But, like anything else, it's not a silver bullet. There are some serious advantages, but also challenges you'll need to navigate to get the most out of the investment. Let's break it down together.

Orodispersible films (ODFs) represent a rapidly evolving dosage form that addresses significant challenges in drug delivery, particularly for patients with difficulty swallowing, such as pediatric, geriatric, and psychiatric populations. ODFs disintegrate rapidly on the tongue, eliminating the need for water and offering benefits such as improved patient compliance, faster onset of action, and enhanced bioavailability. This study evaluates the compatibility and beyond-use dates (BUDs) of 12 ODF formulations compounded in OrPhyllo™, a ready-to-use base specifically designed for ODF production. The active pharmaceutical ingredients (APIs) investigated were baclofen (5 and 10 mg), cetirizine (1.25 and 5 mg), coenzyme Q10 (10 and 50 mg), dextromethorphan (7.5 and 15 mg), ketoprofen (12.5 and 25 mg), loratadine (5 and 10 mg), meloxicam (5 and 20 mg), minoxidil (1 and 10 mg), ondansetron (2 and 8 mg), sildenafil (25 and 50 mg), tadalafil (5 and 20 mg), and tramadol (25 and 50 mg). Comprehensive compatibility studies were conducted to determine the BUD and physicochemical integrity of these formulations by using validated ultra-high-performance liquid chromatography (UHPLC) methods and following guidelines for accelerated and long-term stability testing. No Antimicrobial Effectiveness Testing (AET) was conducted as those are nonaqueous dosage forms. The formulations were stored at room temperature (15-30°C) for up to 180 days, individually packed in matte laminated aluminum sachets. Results revealed the following BUDs for each formulation: baclofen (5 mg - 10 mg): 180 days; cetirizine: 60 days; coenzyme Q10: 180 days; dextromethorphan: 180 days; ketoprofen (12.5 mg): 180 days; ketoprofen (>12 mg - 25 mg): 60 days; loratadine: 180 days; meloxicam: 180 days; minoxidil: 180 days; ondansetron (2 mg): 90 days; ondansetron (>2 mg - 8 mg): 30 days; sildenafil: 180 days; tadalafil: 180 days; tramadol: 150 days. These findings affirm the suitability of OrPhyllo™ as a robust vehicle for compounding ODFs, demonstrating compatibility with APIs across a broad spectrum of clinical applications.

This study comprehensively investigates the physicochemical properties and performance of ophthalmic formulations containing timolol maleate with different polymers. Fourier-transform infrared (FTIR) spectroscopy revealed distinct spectral changes, indicating interactions between timolol maleate and Hydroxyethyl Cellulose (HEC), Xanthan gum, and Gellan gum. Clarity assessments confirmed transparency against white and black backgrounds. pH measurements ensured physiological compatibility (HEC: pH 6.90, Xanthan gum: pH 6.97, Gellan gum: pH 6.98). Evaluation of gelling capacity and strength highlighted Xanthan gum's superiority (Xanthan gum: 180 Pa, Gellan gum: 153 Pa). Viscosity studies demonstrated suitability for ocular use, with pre-gelling values of HEC: 100.11 cps, Xanthan gum: 112.55 cps, Gellan gum: 110.42 cps, and post-gelling values of HEC: 100.01 cps, Xanthan gum: 256.22 cps, Gellan gum: 206.21 cps. Osmolality aligned with ophthalmic norms (HEC: 272 mOsm/kg, Xanthan gum: 290 mOsm/kg, Gellan gum: 285 mOsm/kg). In vitro drug release profiles varied, with Xanthan gum showing sustained release (95.01% over 8 hours). Rabbit eye irritation studies confirmed safety. Stability assessments over three months validated consistent attributes, supporting their potential as effective ophthalmic formulations.

The increasing prevalence of skin conditions like acne, rosacea, and hyperpigmentation highlights the need for personalized dermatological treatments, with compounded formulations providing tailored solutions by combining multiple active pharmaceutical ingredients (APIs). This study evaluates the compatibility and stability of various formulations compounded in Cleoderm™, a cream base designed for acne-prone, affected, or sensitive skin. The tested formulations included: adapalene 0.1% or 0.3% and benzoyl peroxide 1.0% or 5.0%; hydroquinone 4.0%, hydrocortisone 1.0%, and tretinoin 0.0125%; azelaic acid 15.0% or 20.0% and niacinamide 4.0%; niacinamide 4.0% and tretinoin 0.025%; and clindamycin hydrochloride 3.0%. Each formulation underwent high-performance liquid chromatography (HPLC) and microbiological assessments over a 180-day period to determine stability and beyond-use dates (BUDs). Both formulations containing adapalene and benzoyl peroxide demonstrated excellent stability, with an assigned BUD of 180 days. Formulations of azelaic acid combined with niacinamide and niacinamide with tretinoin also showed sustained stability with BUDs of 180 days. In contrast, the formulation containing hydroquinone, hydrocortisone, and tretinoin had a BUD of 14 days. Clindamycin hydrochloride displayed a similar pattern, with stability maintained for 14 days. Microbiological evaluations confirmed the antimicrobial efficacy of all formulations, meeting United States Pharmacopeia (USP) requirements for antimicrobial effectiveness throughout their respective BUDs. The findings underscore the importance of evaluating the stability and compatibility of compounded formulations to ensure their safety and efficacy. This study supports the use of Cleoderm™ as a versatile and reliable base for personalized dermatological treatments, providing evidence-based BUDs to guide clinical practice.