Lean Six Sigma untuk Mengurangi Waste Pada Produksi Tablet Coating A

PT. Medica Indonesia salah satu perusahaan farmasi etikal terbesar di Indonesia. Departement Pilot Plant berperan sebagai fasilitas peningkatan skala setelah skala lab untuk memastikan bahwa QTPP (Quality Target Product Profile) secara konsisten dicapai dalam skala pilot dan skala produksi. Masih tingginya angka reject sebesar 3,6 % dari target reject sebesar 0,5 % pada produk andalan tablet coating A merupakan suatu ancaman. Identifikasi penyebab pemborosan perlu dilakukan untuk peningkatan dan perbaikan pada lini produksi. Penelitian ini melakukan Integrasi Lean Six Sigma dengan menggunakan metode DMAIC, VSM dan VALSAT. Analisa menggunakan tools WRM dan WAQ. Berdasarkan Analisa VALSAT, ditemukan 3 pemborosan terbesar yaitu defect (38,47%), overproduction (16,32%) dan inventory (10,13%). Pemborosan diidentifikasi menggunakan diagram fishbone kemudian dari analisis FMEA menunjukan nilai RPN tertinggi yang dijadikan prioritas usulan perbaikan. Hasil menunjukan pengurangan defect ratio dari 10,35 % menjadi 1,65 % dan pengurangan waste inventory yang diakibatkan overproduction.

Lean Six sigma Integration to Reduce Waste in Tablet coating Production with DMAIC and VSM Approach in Production Lines of Manufacturing Companies

PT. Medica Indonesia was founded in 1969 and is one of the most significant ethical pharmaceutical companies in Indonesia. PT. Medica Indonesia, located in Cikarang, has a Pilot Plant Department that acts as a scale-up facility after lab scale to ensure that QTPP (Quality Target Product Profile) is consistently achieved on a pilot scale and a production scale. The high reject rate of 3.6% of the reject target of 0.5% for Tablet coating A products is a threat to the company because it can reduce productivity at PT. Medica Indonesia. Moreover, the Tablet coating A product is a mainstay product. In improving and improving the production line, it is necessary to identify the causes of waste. The integration of Lean Six Sigma using the DMAIC, VSM and VALSAT methods is an effective way to determine waste and the causes of waste. The analysis stage was carried out using the WRM and WAQ tools and determining recommendations for improvement using FMEA.

I Spy with My Little Eye: A Paediatric Visual Preferences Survey of 3D Printed Tablets

3D printing (3DP) in the pharmaceutical field is a disruptive technology that allows the preparation of personalised medicines at the point of dispensing. The paediatric population presents a variety of pharmaceutical formulation challenges such as dose flexibility, patient compliance, taste masking and the fear or difficulty to swallow tablets, all factors that could be overcome using the adaptable nature of 3DP. User acceptability studies of 3D printed formulations have been previously carried out in adults; however, feedback from children themselves is essential in establishing the quality target product profile towards the development of age-appropriate medicines. The aim of this study was to investigate the preference of children for different 3D printed tablets (Printlets™) as an important precursor to patient acceptability studies. Four different 3DP technologies; digital light processing (DLP), selective laser sintering (SLS), semi-solid extrusion (SSE) and fused deposition modeling (FDM) were used to prepare placebo printlets with similar physical attributes including size and shape. A single-site, two-part survey was completed with participants aged 4–11 years to determine their preference and opinions based on visual inspection of the printlets. A total of 368 participants completed an individual open questionnaire to visually select the best and worst printlet, and 310 participants completed further non-compulsory open questions to elaborate on their choices. Overall, the DLP printlets were the most visually appealing to the children (61.7%) followed by the SLS printlets (21.2%), and with both the FDM (5.4%) and SSE (11.7%) printlets receiving the lowest scores. However, after being informed that the SSE printlets were chewable, the majority of participants changed their selection and favoured this printlet, despite their original choice, in line with children’s preference towards chewable dosage forms. Participant age and sex displayed no significant differences in printlet selection. Printlet descriptions were grouped into four distinct categories; appearance, perceived taste, texture and familiarity, and were found to be equally important when creating a quality target product profile for paediatric 3D printed formulations. This study is the first to investigate children’s perceptions of printlets, and the findings aim to provide guidance for further development of paediatric-appropriate medicines using different 3DP technologies.

Quality by Design: Development of the Quality Target Product Profile (QTPP) for Semisolid Topical Products

In recent years, the “quality by design” (QbD) approach has been used for developing pharmaceutical formulations. This is particularly important for complex dosage forms such as topical semisolid products. The first step for developing a product using this efficient approach is defining the quality target product profile (QTPP), a list of quality attributes (QAs) that are required to be present in the final product. These quality attributes are affected by the ingredients used as well as manufacturing procedure parameters. Hence, critical material attributes (CMAs) and critical process parameters (CPPs) need to be specified. Possible failure modes of a topical semisolid product can be determined based on the physiochemical properties of ingredients and manufacturing procedures. In this review, we have defined and specified QTPP, QAs, CMAs and CPPs that are required for developing a topical semisolid product based on the QbD approach.

Macro- and Micro-Heterogeneity of Natural and Recombinant IgG Antibodies

Recombinant monoclonal antibodies (mAbs) intended for therapeutic usage are required to be thoroughly characterized, which has promoted an extensive effort towards the understanding of the structures and heterogeneity of this major class of molecules. Batch consistency and comparability are highly relevant to the successful pharmaceutical development of mAbs and related products. Small structural modifications that contribute to molecule variants (or proteoforms) differing in size, charge or hydrophobicity have been identified. These modifications may impact (or not) the stability, pharmacokinetics, and efficacy of mAbs. The presence of the same type of modifications as found in endogenous immunoglobulin G (IgG) can substantially lower the safety risks of mAbs. The knowledge of modifications is also critical to the ranking of critical quality attributes (CQAs) of the drug and define the Quality Target Product Profile (QTPP). This review provides a summary of the current understanding of post-translational and physico-chemical modifications identified in recombinant mAbs and endogenous IgGs at physiological conditions.