scholarly journals THE IMPACT OF THE LUBRICATION STEP WITH MAGNESIUM STEARATE ON THE QUALITY TARGET PRODUCT PROFILE OF A MODIFIED RELEASE ORAL DOSAGE FORM CONTAINING A BCS CLASS II ACTIVE PHARMACEUTICAL INGREDIENT

FARMACIA ◽  
2020 ◽  
Vol 68 (3) ◽  
pp. 526-531
Author(s):  
PAUL ANCU DUMITRAȘCU
Keyword(s):  
Dosage Form ◽  
Active Pharmaceutical Ingredient ◽  
Magnesium Stearate ◽  
Oral Dosage ◽  
Modified Release ◽  
Target Product Profile ◽  
Bcs Class Ii ◽  
Product Profile ◽  
The Impact ◽  
Quality Target Product Profile

Intravenous-to-Oral Stepdown Program: Four Years of Experience in a Large Teaching Hospital

1992 ◽  
Vol 26 (11) ◽  
pp. 1447-1451 ◽  
Author(s):  
Luciana Frighetto ◽  
Donna Nickoloff ◽  
Shelagh M. Martinusen ◽  
Fatima S. Mamdani ◽  
Peter J. Jewesson
Keyword(s):  
Dosage Form ◽  
Tertiary Care ◽  
Cost Savings ◽  
Baseline Period ◽  
Oral Route ◽  
Relative Increase ◽  
Oral Dosage ◽  
Oral Antibiotic ◽  
Prescribing Trends ◽  
The Impact

OBJECTIVE: To assess the impact of an intravenous-to-oral (iv-po) stepdown program on the relative use of oral and parenteral dosage forms of select antimicrobials. DESIGN: A retrospective review of drug utilization records before and after a trial comparing metronidazole and clindamycin prescribing trends from a 12-month baseline period to a four-year follow-up period. SETTING: One thousand-bed Canadian tertiary care referral teaching center. INTERVENTION: An authorized iv-po stepdown program was developed to promote the oral route of drug administration. Reminders of iv-po stepdown were produced for metronidazole and clindamycin and these notes were sent to nursing units with the parenteral dosage form. The notes then were attached to the front of the health record to serve as a reminder to prescribers that an equally effective, well-tolerated, and less-expensive oral dosage form was available for use. RESULTS: A 44 percent relative increase in the use of oral metronidazole and a 79 percent relative increase in the use of oral clindamycin occurred. When acquisition and delivery costs were considered, cumulative cost savings from 1988 to 1991 resulted for metronidazole ($31920) and clindamycin ($53880). CONCLUSIONS: This intervention represents a simple yet effective method of promoting a process of stepdown from parenteral to oral antibiotic therapy.

scholarly journals Lean Six Sigma untuk Mengurangi Waste Pada Produksi Tablet Coating A

Jurnal PASTI ◽  
2021 ◽  
Vol 14 (3) ◽  
pp. 255
Author(s):  
Muhammad Kholil, M.T. ◽  
Dhita Savira Oktaandhini ◽  
Adizty Suparno
Keyword(s):  
Six Sigma ◽  
Pilot Plant ◽  
Lean Six Sigma ◽  
Target Product ◽  
Target Product Profile ◽  
Tablet Coating ◽  
Product Profile ◽  
Quality Target Product Profile

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.

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

Pharmaceutics ◽  
2020 ◽  
Vol 12 (11) ◽  
pp. 1100
Author(s):  
Patricija Januskaite ◽  
Xiaoyan Xu ◽  
Sejal R. Ranmal ◽  
Simon Gaisford ◽  
Abdul W. Basit ◽  
...  
Keyword(s):  
Fused Deposition Modeling ◽  
Taste Masking ◽  
Disruptive Technology ◽  
Target Product ◽  
Target Product Profile ◽  
Patient Acceptability ◽  
Fused Deposition ◽  
Product Profile ◽  
3D Printed ◽  
Quality Target Product Profile

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.

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

Pharmaceutics ◽  
2020 ◽  
Vol 12 (3) ◽  
pp. 287 ◽  
Author(s):  
Sarika Namjoshi ◽  
Maryam Dabbaghi ◽  
Michael S. Roberts ◽  
Jeffrey E. Grice ◽  
Yousuf Mohammed
Keyword(s):  
Quality By Design ◽  
Failure Modes ◽  
Pharmaceutical Formulations ◽  
Quality Attributes ◽  
Target Product ◽  
Design Development ◽  
Target Product Profile ◽  
Critical Material ◽  
Product Profile ◽  
Quality Target Product Profile

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.

scholarly journals Pelletization Techniques. The Pharma Review

2019 ◽  
pp. 690-700
Author(s):  
Harsha V Sonaye ◽  
Mohmad Rafik Y. Shaikh ◽  
Rubina Shaikh
Keyword(s):  
Dosage Form ◽  
Oral Dosage ◽  
Modified Release ◽  
Factors Affecting ◽  
Manufacturing Techniques ◽  
Extrusion Technology ◽  
High Degree ◽  
Hot Melt ◽  
Extrusion Spheronization ◽  
Binder Solution

Pellets are spherical or nearly spherical, free-flowing granules with a narrow size distribution, typically varying between 500 and 1500 µm for pharmaceutical applications. They are generally produced via a pelletization process whereby a powder blend consisting of an API and excipients particles is agglomerated into spherical granules. This review article deals with various aspects of the extrusion–spheronization technique. Pelletization is a technique to convert drugs or excipients to small free flowing, spherical or semi spherical units, which are produced by agglomerating fine powdered drugs/ excipients with a binder solution. Pellets range in size, typically, between 0.5 – 2 mm. In relation to pharmaceuticals, pellets offer high degree of flexibility in design and development of oral dosage form. Pelletization technique help in the formation of spherical beads or pellets having a diameter 0.5 -1.5 mm which can be eventually coated for preparation of modified release dosage form. The manufacturing techniques include Drug layering, Extrusion-Spheronization, Cryopelletization, Compression, Balling, Hot-Melt Extrusion Technology, Freeze pelletization, Spray-drying & Spray-congealing. Factors affecting pelletization technique and advantages, disadvantages of pellets are discussed.

scholarly journals Development, characterization and solubility enhancement of BCS class II drug phenytoin by solid phospholipid dispersion technique

2020 ◽  
Vol 11 (1) ◽  
pp. 403-410
Author(s):  
Veera Venkata Satyanarayana Reddy Karri ◽  
Sathish Ananthan ◽  
Lavanya Mude
Keyword(s):  
Freeze Drying ◽  
Dosage Form ◽  
Aqueous Solubility ◽  
Class Ii ◽  
Oral Dosage ◽  
Bcs Class Ii ◽  
The Poor ◽  
Phospholipid Nanoparticles ◽  
Model Drug ◽  
Form Development

The poor aqueous solubility acts as a core challenge in oral dosage form development for BCS class II drugs. Phenytoin is taking as a model drug; the present study adopted an innovative solid phospholipid nanoparticle (SPLN) line of attack, and it is parallelly equated with the industrialized methods (freeze-drying) which are used for the boosting of solubility and dissolution of Phenytoin. Phenytoin was articulated along with phospholipid and mannitol at a diverse ratio of phenytoin, PL, mannitol, in which 1:12:18 was the correct ratio for ideal preparation. Freeze-drying helps to prepare SPLNs in orbicular shape, which is amorphous in nature with ≤ 1µm diameter on average. While the amorphous matrix-like structure of solid phospholipid dispersion with larger particle size is obtained by freeze-drying technique. Formulating the formulation from this method improved the dissolution rate in a remarkable way. Tris buffer with pH 7.4acts as an apparent solubility dissolved concentration of phenytoin. The poor aqueous solubility acts as a core challenge in oral dosage form development for BCS class II drugs. The decrease in the particle size or cumulating the drug surface area is the widely used practices to proliferate the solubility. The target of the present work was improvisation in solubility, dissolution of a poorly water-soluble drug, and its release by using solid phospholipid nanoparticles. Phenytoin is taking as a model drug. The solid phospholipid nanoparticles were primed by freeze-drying technique along with phospholipid and mannitol in diverse drug to excipients ratios (1:1, 1:2w: w). These preparations were assessed for compatibility study using FTIR, solubility enhancement study by XRD, entrapment efficiency, surface morphology by SEM, and in-vitro release study. As per the results, there is no influence of the excipients on the drug used. The solubility was increased by folds compared to in house prepared formulation. 

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