Search

Background: Cutaneous leishmaniasis (CL) topical treatments may have low efficacy, while systemic treatments have adverse effects (AEs) and high cost. Since treatment options for CL nowadays have numerous disadvantages, an alternative topical treatment is vastly needed. We assessed liposomal amphotericin B gel (LAmB gel) treatment efficacy and safety. Methods: A randomized, double‐blind, placebo‐controlled trial. Adults with CL (PCR proven, ≤5 lesions) were randomized for 28 days with LAmB gel (cases) versus placebo gel (controls), followed by LAmB gel for 28 days (both groups). Lesion size, ulceration, induration, scarring, swelling, and AEs (pain, itch, erythema, discharge, fever, and urticaria) were assessed at days 1, 28, and 56. PCR was repeated at day 56. Results: Thirteen patients (four cases, nine controls) with 39 lesions (11 cases, 28 controls) caused by Leishmania major (L. major) were randomized. Ulcer, induration, scarring, and swelling were noted in 18%, 91%, 0%, and 27% of cases, respectively, versus 86%, 89%, 7%, and 54% of controls, respectively. At day 28, improvement rates were low in both groups. Induration improved comparing LAmB gel treatment for 56 days versus 28 days. Ulceration, induration, and swelling improved comparing all patients at 56 days versus 28 days. PCR turned negative in three of four cases and eight of nine controls. Mild, only local, AEs were reported in <30% of the patients. Conclusions: LAmB gel is safe and may be considered as an alternative topical treatment for CL caused by L. major. Further, larger‐scale studies are warranted to evaluate the long‐term impact of LAmB gel on the management of CL. [ABSTRACT FROM AUTHOR]

Background: Melasma is an acquired disorder of hyperpigmentation, affecting a million individuals worldwide. Energy‐based devices (EBDs) employed to treat melasma include various types of lasers, intense pulsed light (IPL), and radiofrequency (RF). Recent studies have attempted to address recalcitrant and recurring melasma by combining energy‐based devices with topical or oral medications. Objective: This article reviews EBDs‐based augmented treatment for melasma and suggests practical pathogenesis‐oriented treatment regimens. Treatment algorithms are proposed to address various components of melasma. Methods: A systematic PubMed search was conducted acquiring information from various studies on combination treatments of melasma involving EBDs. Results: The 286 retrieved articles were filtered by title to contain at least one type of energy‐based modality such as laser, IPL, or RF along with at least one other treatment method. Based on their subject matter, combinations were further categorized into the subheadings: laser plus medication, laser plus laser, and IPL‐ and RF‐containing treatment methods. Conclusion: There are many energy‐based combination treatments that have been explored for mitigation of melasma including laser therapy with medication, multi‐laser therapies, IPL, RF, and microneedling devices. Melasma is an exceedingly difficult condition to treat, however, choosing the appropriate tailor‐made treatment combination can improve the final outcome. [ABSTRACT FROM AUTHOR]

Objective: To update the clinical practice guidelines for the management of oral mucositis (OM) that were developed by the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO). This part focuses on honey, herbal compounds, saliva stimulants, probiotics, and miscellaneous agents.Methods: A systematic review was conducted by the Mucositis Study Group of MASCC/ISOO. The body of evidence for each intervention, in each clinical setting, was assigned an evidence level. The findings were added to the database used to develop the 2014 MASCC/ISOO clinical practice guidelines. Based on the evidence level, one of the following guidelines were determined: Recommendation, Suggestion, No Guideline Possible.Results: A total of 78 papers were identified within the scope of this section, of which 49 were included in this review and merged with nine publications that were reported in the previous guidelines update. A new Suggestion was made for honey (combined topical and systemic delivery) for the prevention of OM in head and neck cancer patients receiving radiotherapy with or without chemotherapy. A new Suggestion clarified that chewing gum is not effective for the prevention of OM in pediatric patients with hematological or solid cancer treated with chemotherapy. No guideline was possible for other interventions.Conclusions: Numerous natural products and herbal remedies were studied for the management of OM. Of the agents reviewed in this systematic review, a guideline in favor was made for honey (combined topical and systemic), while a guideline against was made for chewing gum. Additional research is warranted to clarify the potential of other interventions. [ABSTRACT FROM AUTHOR]

Limited efficacy, costs, side-effects and complications are issues of concern for most current therapeutic modalities for focal hyperhidrosis. This study evaluated the efficacy of topical oxybutynin 10% gel in treating 61 patients with primary focal hyperhidrosis. The gel was applied to the right or left axilla, palms or soles vs. a placebo compound to the contralateral side for 30 days. A blinded visual grading of the change in starchiodine tests was performed by 2 non-involved physicians. The Hyperhidrosis Disease Severity Scale (HDSS) and Dermatology Life Quality Index (DLQI) questionnaires were administered before and after treatment. The patients rated their satisfaction with treatment. Fifty-three patients completed the 4-week treatment. Sweat reduction in the drug-treated sweating areas was higher than in the control-treated areas. There was a significant mean improvement in pre- and posttreatment HDSS and DQLI (p = 0.001 for both). Thirtynine subjects (74%) reported moderate-to-high satisfaction. Twice-daily topical application of oxybutynin 10% gel appears to be an effective, safe and well-tolerated treatment for focal primary hyperhidrosis. [ABSTRACT FROM AUTHOR]

A Correction to this paper has been published: https://doi.org/10.1007/s00520-021-06141-9 [ABSTRACT FROM AUTHOR]

Although pilocarpine hydrochloride tablets are currently indicated for the treatment of xerostomia, their adverse effects are frequently reported. The development of a new, low-dose pilocarpine solution for topical oral-cavity use is needed. This article discusses a few clinical trials to formulate a topical low-dose solution of pilocarpine hydrochloride for the treatment of xerostomia and presents two low dose, stable formulations of pilocarpine topical spray that can improve the patient's quality of life with minimal adverse effects., (Copyright© by International Journal of Pharmaceutical Compounding, Inc.)

Cutaneous leishmaniasis is the most common form of leishmaniasis with global incidence of about 1.5 million cases annually. The disease is endemic in Israel and caused by two types, leishmania major and leishmania tropica. The two types of cutaneous leishmaniasis in Israel are not life threatening, but the multiple skin lesions developed from the contaminated sandfly bites cause significant damage to the quality of life for a few months in patients with leishmania major and sometimes for more than a year in patients with leishmania tropica. Topical treatment for this localized skin disease is very attractive although only one medication is registered in Israel (15% paromomycin +12% methylbenzethonium chloride ointment) for the topical treatment of leishmania major. Two significant disadvantages characterize this topical medication, 1) relatively low efficacy and 2) significant irritation and pain. This article represents part 3 of a 3-part article on the topic of cutaneous leishmaniasis. Part 1 discussed the treatment option of amphotericin-B liposomal gel, part 2 discussed the treatment option of paromomycin sulfate liposomal gel, and this final part (3) discusses the treatment option of photodynamic therapy., (Copyright© by International Journal of Pharmaceutical Compounding, Inc.)

Barrett's esophagus refers to an abnormal change in the cells of the lower portion of the esophagus. It is characterized by the replacement of the normal stratified squamous epithelium lining of the esophagus by columnar epithelium cells which are usually found lower in the gastrointestinal tract. The medical significance of this pathology is approximately 0.5% risk to develop esophageal adenocarcinoma (per patient diagnosed with Barrett's esophagus per year). Diagnosis requires endoscopy and biopsy. In general, high-grade dysplasia and early stages of adenocarcinoma can be treated by endoscopic resection and/or endoscopic ablative therapy, whereas advanced stages (submucosal) are generally advised to undergo surgical treatment. Patients who undergo endoscopic resection and/or endoscopic ablative therapy might suffer from retrosternal discomfort and transient dysphagia, adverse effects that sometimes accompanies these procedures. One of the common post-procedural treatments is sucralfate 1 g 3 to 4 times daily for two weeks after the procedure. The rational for this treatment is to enhance the wound-healing process in the esophagus tissues and to coat the wounded tissues with a cytoprotective agent. As no clinical trials have been performed in order to prove the efficacy of sucralfate in the postprocedural treatment of Barrett's esophagus, this article summarizes the clinical experience accumulated from the treatment with sucralfate as a wound-healing enhancer. In addition, the article deals with the hypothesized mechanism of action of sucralfate and gives one option for compounding sucralfate oral viscous gel., (Copyright© by International Journal of Pharmaceutical Compounding, Inc.)

Cutaneous leishmaniasis is the most common form of leishmaniasis with global incidence of about 1.5 million cases annually. The disease is endemic in Israel and caused by two types, leishmania major and leishmania tropica. The two types of cutaneous leishmaniasis in Israel are not life threatening, but the multiple skin lesions developed from the contaminated sand fly bites cause significant damage to the quality of life for a few months in patients with leishmania major and sometimes for more than a year in patients with leishmania tropica. Topical treatment for this localized skin disease is very attractive although only one medication is registered in Israel (15% paromomycin +12% methylbenzethonium chloride ointment), which is for the topical treatment of "leishmania major." Two significant disadvantages characterize this topical medication, 1) relatively low efficacy and 2) significant irritation and pain, which could result in failure of the registered treatment. This article (part 2 of a 3-part article), which also includes a compounded formulation, discusses the treatment option of paromomycin sulfate liposomal gel (free of the sensitizing methylbenzethonium chloride)., (Copyright© by International Journal of Pharmaceutical Compounding, Inc.)

Cutaneous leishmaniasis is the most common form of leishmaniasis with global incidence of about 1.5 million cases annually. The disease is endemic in Israel and caused by two types, Leishmania major and Leishmania tropica. The two types of cutaneous leishmaniasis in Israel are not life threatening, but the multiple skin lesions developed from the contaminated sandfly bites cause significant damage to the quality of life for a few months in patients with Leishmania major and sometimes for more than a year in patients with Leishmania tropica. The disease ends spontaneously, often with disfiguring scars. The aim of the treatment is to significantly shorten the wound-healing process, hopefully with minimal scars and with parasite eradication. Topical treatment for this localized skin disease is very attractive, although only one medication is registered in Israel (15% paromomycin +12% methylbenzethonium chloride ointment), which is for the topical treatment of "Leishmania major." Relatively low efficacy and significant irritation and pain are two significant disadvantages that characterize this topical medication and could result in failure of the registered treatment. This article, which is presented in 3 parts, discusses three options in the treatment of cutaneous leishmaniasis, 1) amphotericin B liposomal gel and 2) paromomycin sulfate liposomal gel (free of the sensitizing methylbenzethonium chloride), both of which the author considers as efficacious in the treatment of cutaneous leishmaniasis, although to confirm these claims, randomized controlled trials must be conducted, and 3) photodynamic therapy. Most of the reports claim that the photodynamic therapy can achieve results above 90% healing of wounds in a relatively short period of time and with relatively minimal scars. However, a caveat must be held since some of these studies indicate that not all healed wounds become free of the parasite. The daylight option of photodynamic therapy is an interesting modality which abolishes the need for an expensive artificial light source and expensive hospitalization time and enables ambulatory treatment to be efficacious against both types of Leishmania in Israel. Formulations are provided for the three modalities, with the third option being based on 5-aminolevulinic acid hydrochloride as the photosensitizer for this therapy., (Copyright© by International Journal of Pharmaceutical Compounding, Inc.)

This represents part 2 of a 2-part article on the topic of primary focal hyperhidrosis. Part 1, which was published in the International Journal of Pharmaceutical Compounding's January/February 2019 issue, provided a comprehensive review of the active pharmaceutical ingredients aluminum salts and methenamine in the treatment of primary focal hyperhidrosis. Part 2 provides a comprehensive review of the active pharmaceutical ingredients glycopyrronium salts and oxybutynin chloride in the treatment of primary focal hyperhidrosis., (Copyright© by International Journal of Pharmaceutical Compounding, Inc.)

Schizophrenia is a serious, disabling, enduring, and relapsing mental illness which causes problems with the ability to think, feel, and perceive things clearly. One cause of relapse and readmission to a hospital is poor compliance with antipsychotic medication, often due to its adverse effects. Schizophrenia may also affect a person's insight, interfering with their ability to appreciate the benefit of taking medication long term. The relapse rate is significantly higher in those who have discontinued antipsychotic medication. Penfluridol is an unusual, potent, long-acting, first-generation, oral antipsychotic agent indicated for the treatment of chronic schizophrenia, acute psychosis, and Tourette syndrome. It may be considered a depot medication, as it is administered once a week. Despite this positive analysis, and the unique added value of this medication to psychotic, non-compliant patients, Janssen-Cilag, the sole manufacturer of penfluridol worldwide, decided to stop production in 2009. This decision forced many psychotic patients worldwide to abandon the once-a-week convenient treatment and to replace it with a daily, oral treatment or a depot injection. Because penfluridol is no longer commercially available, it has created an opportunity for compounding pharmacists worldwide to accept this challenge and offer this medication to psychiatrists because of its clinical therapeutics. For the past 5 years, penfluridol has been available to compounding pharmacists in Israel and has received favorable feedback from physicians and patients., (Copyright© by International Journal of Pharmaceutical Compounding, Inc.)

Primary focal hyperhidrosis is idiopathic, localized, uncontrollable, excessive, and unpredictable sweating beyond what is necessary to regulate body temperature. Primary hyperhidrosis is thought to affect approximately 2% to 3% of the population, and its effect on a patient's quality of life is very significant. Primary focal hyperhidrosis can be managed using various therapeutic options, including drugs (topical and systemic), nonsurgical interventions (e.g., iontophoresis, botulinum toxin injections), and surgery. This article, which is presented in 2 parts, is a comprehensive review of the topical, evidence-based treatments of primary focal hyperhidrosis, and it covers the following active pharmaceutical ingredients: aluminum salts, methenamine, glycopyrronium salts, oxybutynin chloride; the latter 2 ingredients will be discussed in part 2 of this article. This article discusses the evidence-based data that exists from clinical trials that support the use of topical medications to treat the pathology from efficacy and from a safety point of view. This review also discusses compounding considerations for professionally and safely compounding various topical preparations. In addition, a range of relevant formulas are attached to the article and can be used by compounding pharmacists., (Copyright© by International Journal of Pharmaceutical Compounding, Inc.)

Radiotherapy and epidermal growth factor receptor inhibitors, as important representatives of current chemotherapy, are crucial and irreplaceable treatments of modern oncology. These two types of treatments frequently cause severe dose-dependent dermatologic adverse events that can negatively affect a patient's quality of life and compliance and cause inappropriate dose reductions and even treatment brakes. This article aims to emphasize new scientific data, published in peer reviews, regarding new possibilities to manage these debilitating dermatological adverse events. Since part of the scientific findings is new, the responsibility to enable pharmacologic treatment is in the compounding pharmacist domain. The article also suggests new formulations to the new pharmacologic treatment., (Copyright© by International Journal of Pharmaceutical Compounding, Inc.)

The case report discussed in this article illustrates the painful endeavor of a patient who suffered from severe peripheral neuropathic pain and the to-and-from treatment adjustments that are needed before an optimal grade of pain control and an acceptable quality of life could be achieved. The next to optimal treatment was obtained by meticulously adjusting drugs and combining systemic drugs with topical ones. Compounding pharmacists play an important role in offering potent topical preparations that give an important analgesic added value to complex treatments.

Nausea and vomiting in pregnancy can have serious adverse effects on the quality of a woman's life, affecting her occupational, social, and domestic functioning, and her general well-being; therefore, it is very important to treat this condition appropriately and effectively. Evidence-based algorithms support the use of oral pyridoxine alone or combined with doxylamine as first-line treatment. Promethazine or dimenhydrinate, known as a second-line treatment, should be added to the first-line treatment or should be added only to pyridoxine according to different algorithms. In most of the world, there is a lack of approved medicines using this combination approach known as the first-line treatment. Therefore, compounding pharmacists should supply the demand by compounding 10-mg pyridoxine hydrochloride and 10-mg doxylamine succinate slow-release capsules. Since transdermal promethazine does not exist world wide, and, since this medicine has significant added values compared to the oral/rectal dosage forms, compounding pharmacists should offer physicians transdermal promethazine as a second-line therapy in nausea and vomiting in pregnancy. This review summarizes the nausea and vomiting in pregnancy problems and discusses the compounding opportunities that exist in this common and wide-spread pathology in order to improve a woman's quality of life.

Compounding pharmacists throughout the world are compounding a special type of capsule called "slow-release." This type of capsule is a compounding pharmacy application of the commercial hydrophilic matrix tablets. It is a relatively simple system that allows formulating a robust, reliable, and consistent drug system based on 30% w/w to 40% w/w of specific types of hydroxypropyl methylcellulose. The main purpose of these capsules is to attenuate the drug release when there is a clinical need and no commercial medication exists. Five in vitro trials verified and proved this kind of preparation can be compounded by specialized pharmacists achieving substantial attenuation of drug release that resembles the pharmacokinetic profiles of commercial slow-release medications. An in-depth explanation of the mechanism of action of the slow-release capsules is provided. Since the pharmaceutical calculations needed to compound this preparation are time consuming, a suggestion of a faster way to perform these calculations by using a special Excel spreadsheet is provided. The article demonstrates a special table with a comparison between the specifications, results, and conclusions of the five in vitro trials that evaluated the pharmacokinetic rates of compounded slow-release capsules. The regulatory aspect of compounding slow-release capsules is also discussed.

Tetracycline is known as an effective agent in the treatment of recurrent aphthous stomatitis. A less-known treatment option for this pathology is minocycline. Many articles have been published in the International Journal of Pharmaceutical Compounding about recurrent aphthous stomatitis, however, this is the first article published in the journal that concentrates on the evidence-based data of minocycline as a promising agent to treat this pathology in what some scientific reports indicate to be a more efficacious manner than tetracycline. Few options to compound topical preparations based on minocycline and other evidence-based agents are proposed in the treatment of recurrent aphthous stomatitis.

Sodium cromoglicate (cromolyn sodium) is a very well-known medicine that has been used for many years for various allergic conditions. The topical use of this medicine is less known, and there are no commercial medicines of cream, gel, or lotion in most of the world. This article summarizes the clinical data accumulated from seventeen trials that checked the topical efficacy and safety of sodium cromoglicate and analyzes the clinical implementations of this medicine in the topical treatment of atopic dermatitis and other skin allergies. In addition, this article analyzes the various formulations that have been used in the clinical trials in an attempt to find the optimal formulation. The topical use of sodium cromoglicate seemed to have a promising potential, and implementing the data of this article can allow the compounding pharmacist a very interesting professional activity in very common and widespread allergic pathologies.

Eosinophilic esophagitis is a clinicopathologic disease isolated to the esophagus. It is caused by immunologic reactions to ingested and inhaled allergans. Symptoms include regurgitation, vomiting, pain, anorexia, and dysphagia. Endoscopy with biopsy is currently the only reliable diagnostic test for eosinophilic esophagitis. The disease should remit with treatments of dietary exclusion, topical corticosteroids, or both. Oral viscous budesonide is one of the promising options of topical corticosteroid to treat eosinophilic esophagitis. Since there are no commercial medicines of oral viscous budesonide, it is solely a compounded medication. This article briefly discusses the properties of the disease and covers a few compounding possibilities to oral viscous budesonide.

Burning mouth syndrome is a complex pathology for which there is very little information about the etiology and pathogenesis. This lack of knowledge leaves patients with suboptimal treatments. This article discusses the existing scientific evidence about this disease. Since topical oral use of clonazepam have been shown to be effective and safe to treat some patients suffering with burning mouth syndrome, formulations including clonazepam are included with this article. Compounding topical preparations of clonazepam offers opportunities for compounding pharmacists to be more involved in improving the quality of life of burning mouth syndrome patients.

In an article published in the January/February 2012 issue of the International Journal of Pharmaceutical Compounding, damage to the oral mucosa, commonly referred to as oral mucositis, as a result of chemotherapy, radiotherapy, or a combination of both therapies was discussed. his article continues that discussion but in respect to the injury that these rapies cause to the gastrointestinal tract. Like oral mucositis, gastrointestinal mucositis is a significant problem in oncology, as it causes very serious pathologies along the alimentary tract, damaging the quality of life of the oncologic patient, and sometimes the damages are life-threatening. The most vulnerable organs of the gastrointestinal tract to radiation and chemotherapy toxicities are the small intestine, colon, and rectum. This article concentrates on the chronic rectum and anus toxicities of radiotherapy and escribes two compounding preparations to treat chronic radiation induced proctitis with rectal bleeding. As in oral mucositis, although substantial scientific progress has been made in learning more about this pathology, current treatments to manage gastrointestinal mucositis is inadequate.

Oral mucosal damage is one of the common and worst side effects of radiotherapy and chemotherapy treatment for cancer. With prevalence between 10% and 100%, depending on the cytotoxic and/or radiotherapy regimen and patient-associated variables, this morbid condition represents a significant problem in oncology. This article addresses oral mucositis and discusses its prevalence, risk factors, clinical and economical impacts, etiology, and clinical management in view of the most recent evidence. Despite clear progress and the development of clinical guidelines on this topic, what we currently have to offer to patients to manage mucositis and oropharyngeal pain is still inadequate. This article offers two compounded preparations supported by evidence-based data to treat oral mucositis. Expansion of the knowledge of the pathogenesis of mucositis as well as a better insight into individual risk factors will provide opportunities to improve management strategies.

A thrombosed external hemorrhoid is a complication of external hemorrhoids. Usually, this disease is accompanied by severe pain that lasts for several days. The common conservative treatment is a slow, ineffective pain reliever. Surgery produces a lot of discomfort and inconvenience, affects the patient's quality of life, and presents some risks of post-operative complications. The purpose of this article is to propose an elegant compounded preparation to quickly treat the pain associated with thrombosed external hemorrhoids with a minimum of side effects and complications.