Advances in solid dosage form manufacturing technology

2007 ◽  
Vol 365 (1861) ◽  
pp. 2935-2949 ◽  
Author(s):  
Gavin P Andrews
Keyword(s):  
Dosage Form ◽  
Powder Processing ◽  
Dosage Forms ◽  
Oral Dosage ◽  
Pharmaceutical Companies ◽  
Solid Dosage Forms ◽  
Solid Dosage Form ◽  
Solid Dosage ◽  
Manufacturing Technologies ◽  
Hot Melt

Currently, the pharmaceutical and healthcare industries are moving through a period of unparalleled change. Major multinational pharmaceutical companies are restructuring, consolidating, merging and more importantly critically assessing their competitiveness to ensure constant growth in an ever-more demanding market where the cost of developing novel products is continuously increasing. The pharmaceutical manufacturing processes currently in existence for the production of solid oral dosage forms are associated with significant disadvantages and in many instances provide many processing problems. Therefore, it is well accepted that there is an increasing need for alternative processes to dramatically improve powder processing, and more importantly to ensure that acceptable, reproducible solid dosage forms can be manufactured. Consequently, pharmaceutical companies are beginning to invest in innovative processes capable of producing solid dosage forms that better meet the needs of the patient while providing efficient manufacturing operations. This article discusses two emerging solid dosage form manufacturing technologies, namely hot-melt extrusion and fluidized hot-melt granulation.

scholarly journals Hot-Melt 3D Extrusion for the Fabrication of Customizable Modified-Release Solid Dosage Forms

Pharmaceutics ◽  
2020 ◽  
Vol 12 (8) ◽  
pp. 738 ◽  
Author(s):  
Jaemin Lee ◽  
Chanwoo Song ◽  
Inhwan Noh ◽  
Sangbyeong Song ◽  
Yun-Seok Rhee
Keyword(s):  
Dissolution Rate ◽  
Dosage Form ◽  
Amorphous State ◽  
Dosage Forms ◽  
Modified Release ◽  
Solid Dosage Forms ◽  
Solid Dosage Form ◽  
Solid Dosage ◽  
Enhanced Solubility ◽  
Hot Melt

In this work, modified-release solid dosage forms were fabricated by adjusting geometrical properties of solid dosage forms through hot-melt 3D extrusion (3D HME). Using a 3D printer with air pressure driving HME system, solid dosage forms containing ibuprofen (IBF), polyvinyl pyrrolidone (PVP), and polyethylene glycol (PEG) were printed by simultaneous HME and 3D deposition. Printed solid dosage forms were evaluated for their physicochemical properties, dissolution rates, and floatable behavior. Results revealed that IBF content in the solid dosage form could be individualized by adjusting the volume of solid dosage form. IBF was dispersed as amorphous state with enhanced solubility and dissolution rate in a polymer solid dosage form matrix. Due to absence of a disintegrant, sustained release of IBF from printed solid dosage forms was observed in phosphate buffer at pH 6.8. The dissolution rate of IBF was dependent on geometric properties of the solid dosage form. The dissolution rate of IBF could be modified by merging two different geometries into one solid dosage form. In this study, the 3D HME process showed high reproducibility and accuracy for preparing dosage forms. API dosage and release profile were found to be customizable by modifying or combining 3D modeling.

scholarly journals INFORMATION-ALGORITHMIC SUPPORT FOR DEVELOPMENT OF SOLID PHARMACEUTICAL FORM

2018 ◽  
Vol 13 (5) ◽  
pp. 73-81 ◽  
Author(s):  
V. F. Kornushk ◽  
I. V. Bogunova ◽  
A. A. Flid ◽  
O. M. Nikolaeva ◽  
A. A. Grebenshchikov
Keyword(s):  
System Approach ◽  
Dosage Form ◽  
Dosage Forms ◽  
Information Modeling ◽  
Relational Model ◽  
Information Support ◽  
Solid Dosage Forms ◽  
Pharmaceutical Development ◽  
Solid Dosage Form ◽  
Solid Dosage

The article deals with the application of the system approach for constructing informationalgorithmic support for the pharmaceutical development of solid dosage forms. Information modeling of the life cycle of pharmaceutical drug development has been carried out starting from the stage of studying the active pharmaceutical substance and ending with the utilization of the drug. These models are built in the IDEF0 nomination. A generalized block diagram is presented that reflects, in its most general form, the iterative process of developing a ready-made dosage form as applied to the further transfer of technology. The basis of the system approach is QbD - "Quality planned in the development". To implement the QbD principle on the basis of the system approach, systemic set-theoretic models of information support of pharmaceutical development in the nomenclature of Melentiev have been constructed. A model for controlling the pressing process is also provided, which takes into account all the technological stages in the development of a solid dosage form. Functional models in the IDEF0 nomenclature of the technological process are constructed from the preparation of premises, personnel and components of the dosage form to the stage of packing and packaging of the finished dosage form. The construction of an informational intellectual control system for pharmaceutical development has been considered in detail with particular attention paid to the construction of a database of medicinal and auxiliary substances using the example of solid dosage forms. In Melentiev's bracket notation, the database of auxiliary substances necessary for the design of a solid dosage form is filled. The "Entity-relationship" model and the relational model for the database of medicinal and auxiliary substances have been constructe

scholarly journals AN OVERVIEW ABOUT NOVEL FAST DISSOLVING ORAL FILMS

2018 ◽  
Vol 6 (1) ◽  
pp. 1-7 ◽  
Author(s):  
Pravin Kumar Sharma ◽  
Pankaj Kumar Sharma ◽  
Gajanan N Darwhekar ◽  
Birendra Shrivastava
Keyword(s):  
Dosage Form ◽  
Dosage Forms ◽  
Oral Dosage ◽  
Drug Dissolution ◽  
Solid Dosage Forms ◽  
Onset Of Action ◽  
Cold Sore ◽  
Solid Dosage ◽  
Oral Films ◽  
Oral Dosage Forms

Nowadays, novel fast dissolving oral films (FDF) have come in existence as an alternative dosage form in comparison with tablet, capsules, syrup and other oral dosage forms with respect to patient convenience and compliance. Fast dissolving oral films are helpful to paediatric and geriatric patients who experience difficulties in swallowing traditional oral solid-dosage forms. The FDF drug delivery systems are solid dosage form which disintegrate or dissolve within seconds when placed in the mouth cavity without need of water or chewing. FDF provide better drug dissolution, faster onset of action, bypassing the first pass metabolism of drugs and thus enhance their oral bioavailability with reduced dosing frequency. These formulations are suitable for cough, cold, sore throat, allergenic conditions, nausea, pain, hypertension and CNS disorders. The present review provides the details about the recent advancement in design and development of oral fast dissolving film.

scholarly journals REVIEW: FAST DISSOLVING TABLET

2018 ◽  
Vol 10 (2) ◽  
pp. 5
Author(s):  
Aher Smita S. ◽  
Saudagar R. B. ◽  
Shinde Mayuri S.
Keyword(s):  
Dosage Form ◽  
Geriatric Patients ◽  
Oral Route ◽  
Dosage Forms ◽  
Oral Dosage ◽  
Solid Dosage Forms ◽  
Solid Dosage ◽  
Tablet Disintegration ◽  
Physical And Chemical ◽  
Pass Metabolism

Fast dissolving tablets is one of the most widely accepted dosage forms and also most popular dosage form, especially for pediatric patients because of incomplete development of the muscular and nervous system and a case of geriatric patients suffering from Parkinson’s disorder or hand tremors. Some solid dosage forms like tablets and capsules are present days facing the problems like difficulty in swallowing (dysphagia), resulting in many incidences of non-compliance and making the therapy ineffective. Oral dosage form and oral route are the most preferred route of administration for various drugs have limitations like the first-pass metabolism. Fast dissolving tablets are one of them. FDT have benefits such as accurate dosing, easy portability and manufacturing, good physical and chemical stability and an ideal alternative for pediatric and geriatric patients. Some tablets are designed to dissolve fastly in saliva, within a few seconds, and are true fast-dissolving tablets. Others contain agents to enhance the rate of tablet disintegration in the oral cavity and are more appropriately termed fast-disintegrating tablets, as they may take up to a minute to completely disintegrate.

scholarly journals A comprehensive review on pharmaceutical mini tablets

2018 ◽  
Vol 8 (6) ◽  
pp. 382-390 ◽  
Author(s):  
Priyanka Priyanka ◽  
Kapil Kumar ◽  
Deepak Teotia
Keyword(s):  
Dosage Form ◽  
Dosage Forms ◽  
Oral Dosage ◽  
Formulation Development ◽  
Coating Materials ◽  
Solid Dosage Form ◽  
Solid Dosage ◽  
Therapeutic Benefits ◽  
Form Design ◽  
Oral Dosage Forms

Mini-tablets represent a new trend in solid dosage form design, with the main goal of overcoming some therapeutic obstacles. Mini tablets are multiple unit dosage forms and are advantageous than pellets or any other oral dosage forms as they are easy to manufacture and stability problems are less. Offering some therapeutic benefits such as dose flexibility and combined release patterns. They do not require any solvent for their production and also local irritation can be avoided by the use of mini tablet Mini tablet offer several advantages like they can be manufactured relatively easily, They are not require less coating materials and also there is a great flexibility during their formulation development. Mini tablet are more acceptable in children and elderly people as they are easy to swallow. The objective of controlled drug delivery systems is to reduce the frequency of the dosing and to increase the effectiveness of the drug by localization. Keywords: Mini-tablets, solid dosage form, oral dosage forms.

scholarly journals AN OVERVIEW ABOUT NOVEL FAST DISSOLVING ORAL FILMS

2018 ◽  
Vol 6 (1) ◽  
pp. 1-7
Author(s):  
Pravin Kumar Sharma ◽  
Pankaj Kumar Sharma ◽  
Gajanan N Darwhekar ◽  
Birendra Shrivastava
Keyword(s):  
Dosage Form ◽  
Dosage Forms ◽  
Oral Dosage ◽  
Drug Dissolution ◽  
Solid Dosage Forms ◽  
Onset Of Action ◽  
Cold Sore ◽  
Solid Dosage ◽  
Oral Films ◽  
Oral Dosage Forms

Nowadays, novel fast dissolving oral films (FDF) have come in existence as an alternative dosage form in comparison with tablet, capsules, syrup and other oral dosage forms with respect to patient convenience and compliance. Fast dissolving oral films are helpful to paediatric and geriatric patients who experience difficulties in swallowing traditional oral solid-dosage forms. The FDF drug delivery systems are solid dosage form which disintegrate or dissolve within seconds when placed in the mouth cavity without need of water or chewing. FDF provide better drug dissolution, faster onset of action, bypassing the first pass metabolism of drugs and thus enhance their oral bioavailability with reduced dosing frequency. These formulations are suitable for cough, cold, sore throat, allergenic conditions, nausea, pain, hypertension and CNS disorders. The present review provides the details about the recent advancement in design and development of oral fast dissolving film.

scholarly journals Personalised 3D Printed Medicines: Optimising Material Properties for Successful Passive Diffusion Loading of Filaments for Fused Deposition Modelling of Solid Dosage Forms

Pharmaceutics ◽  
2020 ◽  
Vol 12 (4) ◽  
pp. 345 ◽  
Author(s):  
Jose R. Cerda ◽  
Talaya Arifi ◽  
Sejad Ayyoubi ◽  
Peter Knief ◽  
Maria Paloma Ballesteros ◽  
...  
Keyword(s):  
Drug Loading ◽  
Dosage Forms ◽  
Passive Diffusion ◽  
Oral Dosage ◽  
Solubility Parameters ◽  
Support Vector ◽  
Clinical Settings ◽  
Solid Dosage Forms ◽  
Solid Dosage ◽  
3D Printed

Although not readily accessible yet to many community and hospital pharmacists, fuse deposition modelling (FDM) is a 3D printing technique that can be used to create a 3D pharmaceutical dosage form by employing drug loaded filaments extruded via a nozzle, melted and deposited layer by layer. FDM requires printable filaments, which are commonly manufactured by hot melt extrusion, and identifying a suitable extrudable drug-excipient mixture can sometimes be challenging. We propose here the use of passive diffusion as an accessible loading method for filaments that can be printed using FDM technology to allow for the fabrication of oral personalised medicines in clinical settings. Utilising Hansen Solubility Parameters (HSP) and the concept of HSP distances (Ra) between drug, solvent, and filament, we have developed a facile pre-screening tool for the selection of the optimal combination that can provide a high drug loading (a high solvent-drug Ra, >10, and an intermediate solvent–filament Ra value, ~10). We have identified that other parameters such as surface roughness and stiffness also play a key role in enhancing passive diffusion of the drug into the filaments. A predictive model for drug loading was developed based on Support Vector Machine (SVM) regression and indicated a strong correlation between both Ra and filament stiffness and the diffusion capacity of a model BCS Class II drug, nifedipine (NFD), into the filaments. A drug loading, close to 3% w/w, was achieved. 3D printed tablets prepared using a PVA-derived filament (Hydrosupport, 3D Fuel) showed promising characteristics in terms of dissolution (with a sustained release over 24 h) and predicted chemical stability (>3 years at 25 °C/60% relative humidity), similar to commercially available NFD oral dosage forms. We believe FDM coupled with passive diffusion could be implemented easily in clinical settings for the manufacture of tailored personalised medicines, which can be stored over long periods of time (similar to industrially manufactured solid dosage forms).

scholarly journals LYOPHILIZED INJECTION: A MODERN APPROACH OF INJECTABLE DOSAGE FORM

2018 ◽  
Vol 8 (5) ◽  
pp. 10-18
Author(s):  
U Sheena ◽  
KG Parthiban ◽  
R Selvakumar
Keyword(s):  
Patient Compliance ◽  
Freeze Drying ◽  
Dosage Form ◽  
Dosage Forms ◽  
Solid Dosage Forms ◽  
Modern Approach ◽  
Solid Dosage ◽  
Liquid Injection ◽  
Improved Stability ◽  
Injectable Dosage

Now-a-days, lyophilized injection dosage form is extensively used to improve the bioavailability, stability, solubility and patient compliance. The lyophilized injection has considered as alternative to oral solid dosage forms for better patient compliance especially in bed ridden patients and for attaining maximum bioavailability, improved stability. The lyophilized injection reconstitute before injection to produce liquid injection. This review includes a detailed updated concept on lyophilized injection. Keywords: Lyophilized injection, parenteral, freeze drying

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