https://www.bacthera.com/

Furnishing of a galenical laboratory with equipment and excipients for research and development of liquid and semi-solid forms to be liquid-filled into hard capsules for contract research and internal projectsResearch and Development of traditional and novel drug delivery technologies related to GI - targetingWriting of case studies and patents based on the outcome of internal research projects on model compoundsQualification of laboratory equipment (Liquid filling and banding machine, lab process plant, Titrator for Lipolysis)

Development of a mucoadhesive suspension-gel for periodontal pocket delivery from labscale to clinical phase I production scale including full documentation up to CTD Module 3 (3.2.P.1 to 3.2.P.3), Mock FDA audit without major findings passed.Preclinical development of a 2nd Generation biodegradable and sustained delivery system for treatment of the periodontal pocket.Preclinical development of semi-solid formulations for diabetic feet syndrome (aqueous microemulsion gel with vitamin-API and penetration enhancer) and actinic keratosis (w/o cream with API, mineral and silicone-based sunscreens).Capsule filling and coating in labscale for gastric, intestinal and colonic delivery.Establishing of a galenical laboratory for preclinical development of semi-solid forms up to 1kg size.

Development of special delivery systems like microemulsions, pH-modified matrix tablets and minitablets, nanosuspensions.Assessment of drug substances, special delivery systems and inhalation powders via HPLC, UPLC, microscopy, Hotstage microscopy, turbidimetry, calorimetry, XRPD, Polarimetry, NGI, DUSA.Elected as Teamspeaker of ~38 interdisciplinary teammembers, representing them to a global leadership team, organising, educating and leading the team towards self-direction and self-responsibility according to an internal LEAN strategy.Evaluation and introduction of a hotstage microscope, instrumental method of assessing microemulsions via turbidity measurement, method of drying nanoparticles via spray granulation.Experience in (hotstage) microscopy, spray granulation (Hüttlin Mycrolab), high-shear granulation, organisation and management (sort of...) of teams according to LEAN principles.

Performance of Feasibilty studies and manufacturing of solutions and suspensions for DMPK/TOX studies.In-process controlls, short term stability studies and release analytics via HPLC.Contribution to two BA enhancement studies i.v. on a BCS Class II and Class IV drug comparing inclusion complexation, liposomal and liquid/solid microemulsions by developing and manufacturing the galenical formulations.Experience in formulating poorly soluble drugs into suspensions, solutions, microemulsions, cyclodextrin complexes and liposomes with low / acceptable i.v. toxicity of the formulations; Micro to mini - scale feasibility and manufacturing of DMPK/TOX formulations (0.5 to 50ml); short-term stability studies.

Development and Scaling up of a breast firming gel and an eye anti-fatigue roll-on from a 100g to 20kg scale.Development of a hair-straightening spray and a hair shampoo as a foam.Experience in cosmetical hair straigthening and short-timeline formulation development. In-process analytics (Viscosity, color, pH, Microscopy, spreading angle, daylight) and stability studies.

Environmental Analytics applied to assess waste water and exhaust air from a waste-water treatment plant of a production site.Performance of GC and GC-HS (Varian with FID/ECD), IC (Metrohm), wet chemistry/colorimetry, TOC/DOC (Dohrmann, Shimadzu), BSB5, Zahn-Wellens degradation.Contribution to an investigation for reducing TPC by identifying solvent recycling / exhaust air burden gaps in waste water/exhaust air by applying specific sampling methods directly from the involved production plants.Evaluation and Validation of a new IC (Metrohm).

Development of formulations for Inhalation devices (HFA-MDI, MDDPI). Experience in lactose coating, CU/FPF/FPD improvement, HFA emulsification.Development of an analytical procedure for estimating the FPF/FPD via laser diffraction in aerodynamic flow.In-process analytics (Microscopy, particle size, powder characteristics, pressure), stability studies.Analytical measurement of CU/FPF/FPD and water content via TI, MSLI, ACI, DUSA, Karl-Fischer titration and HPLC (Waters, Gynkotek/Dionex).Evaluation of a laser diffraction particle sizer (Sympatec HELOS, RODOS, OASIS, INHALER, Malvern Mastersizer, Spraytec).

Development and Scaling up of semi-solid and liquid and medical shampoo forms on OTC drugs (anti acne/anti dandruff shampoos, NSAID gel and cream, Hydrating emulsifier-free lotion) from a 100g to 500/3000kg scale.Full development of an anti-dandruff shampoo to the market from 100g to 3000kg scale, perfomance of in-process analytics, stability studies, writing of all procedures and protocols up to production scale.Elaboration of Bio-engineering techniques for measuring drug penetration through artificial membranes under supervision.Experience in development of emulsifier-free creams; scaling-up (ESCO, Meprotec/Brogtec 20, 500); In-process analytics (Viscosity, color, pH, Microscopy, spreading angle), stability studies (freeze/thaw cycles, short term, long term) and dermatological measurements in humans (TEWL, skin color, skin fat content, skin pH).

Development and Scaling up of semi-solid and liquid forms on OTC drugs (Eye gel, cough syrup, soft gelatine capsule filling mass, ointments, creams, lotions, vitamin and cough solutions) from a 100g to 300kg scale. Experience in taste masking; writing of SOP's, batch protocols and procedures; development of emulsifier-free creams; scaling-up (ESCO, MMU-20, MMU/FMU-100, 150, 300, Becomix); improvement of semi-solid production procedures (cooling steps, WIP/CIP).In-process analytics (Viscosity, color, pH, Microscopy, spreading angle) and stability studies (freeze/thaw cycles, short term, long term).