Automated Non-Sterile Pharmacy Compounding: A Multi-Site Study in European Hospital and Community Pharmacies with Pediatric Immediate Release Propranolol Hydrochloride Tablets.

Pharmacy compounding, the art and science of preparing customized medications to meet individual patient needs, is on the verge of transformation. Traditional methods of compounding often involve manual and time-consuming processes, presenting challenges in terms of consistency, dosage accuracy, quality control, contamination, and scalability. However, the emergence of cutting-edge technologies has paved a way for a new era for pharmacy compounding, promising to redefine the way medications are prepared and delivered as pharmacy-tailored personalized medicines. In this multi-site study, more than 30 hospitals and community pharmacies from eight countries in Europe utilized a novel automated dosing approach inspired by 3D printing for the compounding of non-sterile propranolol hydrochloride tablets. CuraBlend® excipient base, a GMP-manufactured excipient base (pharma-ink) intended for automated compounding applications, was used. A standardized study protocol to test the automated dosing of tablets with variable weights was performed in all participating pharmacies in four different iterative phases. Integrated quality control was performed with an in-process scale and NIR spectroscopy supported by HPLC content uniformity measurements. In total, 6088 propranolol tablets were produced at different locations during this study. It was shown that the dosing accuracy of the process increased from about 90% to 100% from Phase 1 to Phase 4 by making improvements to the formulation and the hardware solutions. The results indicate that through this automated and quality controlled compounding approach, extemporaneous pharmacy manufacturing can take a giant leap forward towards automation and digital manufacture of dosage forms in hospital pharmacies and compounding pharmacies.

Topical everolimus for facial angiofibromas in the tuberous sclerosis complex. A first case report.

BACKGROUND: Facial angiofibromas are present in most of the patients with the tuberous sclerosis complex and may cause severe disfiguration of the face. The tumor growth in tuberous sclerosis complex is promoted by the disinhibition of the mammalian target of rapamycin pathway. Thus, the systemic treatment with mammalian target of rapamycin inhibitors such as sirolimus and everolimus has recently been established to treat specific tuberous sclerosis complex-associated lesions. For patients who suffer from disfiguring facial angiofibromas only, there is a need for a topical use of mammalian target of rapamycin inhibitors. Sirolimus has been shown to be beneficial in treating facial angiofibromas. But the topical use of everolimus, which has the approval to treat tuberous sclerosis complex-associated tumors, namely giant cell astrocytomas and renal angiofibromas, has not been reported. PATIENTS AND RESULTS: We present a 10-year-old girl whose facial angiofibromas were successfully treated with an everolimus ointment without relevant side effects. In addition, we provide a short pharmacological overview of sirolimus and everolimus with focus on the topical use. CONCLUSIONS: Topical everolimus seems to be a favorable and safe option for patients with facial angiofibromas who do not require systemic treatment.

[How do the antibodies get into the chicken egg? ]

In this article the term IgG is used instead of IgY because it is the immunoglobulin in the chicken which relates physiologically strongest to the mammalian IgG. The IgG is transported into the ripening oocytes from the circulation of the hen by receptors. Additionally traces of IgA are being transferred into the oocytes. IgM traces in the yolk-sack are most likely synthesized there. Also, an infiltration of IgA and IgM into the egg-white may occur during the passage through the oviduct. The antibodies are being moved between five compartments: egg-white- and yolk-sack, amnion, allantois and blood circulation. During incubation these compartments change their volume dynamically wherefore exact balances are difficult to calculate.

[Lipopeptides as adjuvants for the immunisation of laying hens]

Increasing interest on the extraction of specific antibodies from chicken egg yolk rises the question for powerful adjuvants without side effects for the IMMUNISATION of laying hens. The Lipopeptides Pam3Cys-Ser-(Lys)4 (PCSL) showed effective immunostimulating capacity in case of the immunization of chickens with a viral antigen. The specific antibody contents of the sera were comparable to and sometimes even significantly higher than those achieved with complete Freund"s adjuvans (CFA). Considering the immunization of laying hens with recombinant bovine somatotropin, the use of a combination of PCSL with a novel lipopeptide (PCSTH16) for the primary immunization did not result in higher specific antibody titers compared to the groups which received only one adjuvant. The correlation between the contents of specific antibodies in the sera and those of the egg yolks collected a week later were 0.81 (CFA) and 0.86 (PCSL) in case of the viral antigen and between 0.59 and 0.88 with recombinant bovine somatotropin using lipopeptides as adjuvants.

Production and Purification of Mouse IgG Subclass Specific Chicken Egg Yolk Antibodies Using a New Indirect Affinity Chromatography Method with Protein G Sepharose.

Chicken antibodies have been reported to be an excellent alternative to the mammalian antibodies, especially if the antigen is from mammalians. Because chicken immunoglobulin Y (IgY) does not bind to protein G, in this study a indirect method for the purification of murine immunoglobulin G (IgG) subclass specific egg yolk antibodies is described. After preincubation of the chicken egg antibodies (e.g. from hens immunized against murine IgG1) with the non corresponding murine IgG subclasses (e.g. IgG2a and IgG2b) and purification with protein G sepharose, subclass specific chicken antibodies (e.g. against IgG1) could be isolated from precipitated egg yolk antibodies. Specificities of the egg yolk antibodies were determined in a competitive ELISA and immunoblot. Therefore, the indirect affinity chromatography with protein G provides a efficient method for purifying specific chicken egg antibodies against mammalian IgG subclasses.