scholarly journals Updated List of Light-Sensitive Oral Medications

2019 ◽  
Vol 55 (6) ◽  
pp. 349-365
Author(s):  
Scott Perkins ◽  
Adam Evans ◽  
Allison King
Keyword(s):  
Dosage Form ◽  
Drug Information ◽  
Dosage Forms ◽  
Drug Products ◽  
Solid Dosage ◽  
Oral Medications ◽  
Information Center ◽  
Oral Liquid ◽  
Liquid Products ◽  
Professional Resources

The Campbell University Drug Information Center supports health professionals by providing responses to drug-related inquiries. An inquiry was received by the Drug Information Center for a comprehensive list of oral solutions which should be protected from light. In investigating this request for information, a list of light-sensitive oral prescription drug products published in Hospital Pharmacy in 2009 was identified. This discovery highlighted the need for both an updated list and one which distinguished oral solid products and oral liquid products. The purpose of this project was to update the previously published list and to distinguish between oral solid and liquid dosage forms. The process of updating this list entailed several professional resources. A list of all oral products was obtained and then sorted to clearly identify which products were available in oral solid dosage form only, oral liquid dosage form only, and both dosage forms. Once delineated, the product labels for each medication were scoured for language indicating the product is light sensitive.

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

Foreign Drug Identification

DICP ◽  
1989 ◽  
Vol 23 (6) ◽  
pp. 501-506
Author(s):  
Lu-Ann L. Murdoch
Keyword(s):  
Drug Information ◽  
Background Information ◽  
Reference Library ◽  
Identification Process ◽  
Drug Products ◽  
Drug Identification ◽  
Information Center

The references used by a major Canadian drug information center to identify foreign drug products are described. Guidelines are provided for handling foreign drug identification requests, including the collection of background information and the management of specific problems likely to be encountered during the identification process. Useful methods of building a foreign drug identification reference library are also suggested.

scholarly journals P47 Extent of paediatric exposure to pharmaceutical excipients: an exploratory study

2020 ◽  
Vol 105 (9) ◽  
pp. e31.1-e31
Author(s):  
Mohammed AbouDaya ◽  
Stephen Tomlin ◽  
Asia N Rashed
Keyword(s):  
Propylene Glycol ◽  
Dosage Forms ◽  
List Type ◽  
Liquid Formulation ◽  
Solid Dosage Forms ◽  
Patient Factors ◽  
Solid Dosage ◽  
Oral Liquid ◽  
Harmful Excipients

AimThe assumption that excipients are inactive therefore non-harmful to patients is a declining opinion due to raised safety concerns of excipient activity, particularly in children.1 There is limited data on the safety of excipients in children and a lack of standardisation of the risk-benefit use of excipients in the different paediatric populations.2 This study aimed to investigate the extent of excipient exposure in children taking long-term oral liquids, admitted to Hospital, and to identify whether patients could be switched to a solid alternative due to the harm posed from liquid formulations.MethodA prospective observational study conducted in a UK paediatric hospital. The electronic medication chart for hospitalised children aged 0–18 years on long-term (for ≥6 weeks) oral liquid medicines, were reviewed over a four-week period. A priority list of eight excipients (called harmful excipients) with known reported hazards was developed based on literature: propylene glycol, ethanol, parabens, benzyl alcohol, aspartame, sorbitol, polysorbate 80 and benzoic acid. The list was used to determine the extent of children exposure to the harmful excipients. Considering patient factors (age, swallowing ability, treated condition), prescribed dose and availability of solid dosage forms, the included long-term liquid medicines were assessed for a potential solid form alternative by a specialist paediatric clinical pharmacist.ResultsA total of 302 oral liquid medicine formulations prescribed for 60 patients (age range 10 days – 17 years) were included in the study, of which 68.9% (208/302) were long-term oral liquid formulations. The 208 oral liquid formulation contained a total of 1044 excipients resulted in 17.4 (± 9) excipients per patients. Majority of patients (98.3%, 59/60) were exposed to at least one harmful excipient in their medicines. Children aged 2–11 years and 6–11 years were exposed the most to harmful excipients (mean 8.2 ± 4.9 exposure per patient). Parabens (81.7%, 49/60) was the most common harmful excipient patients were exposed to, followed by sorbitol (76.7%, 46/60), ethanol (75.0%, 45/60) and propylene glycol (70.0%, 42/60). Considering patient factors, prescribed dose and availability of solid formulations, it was found that almost third of the prescribed long-term oral liquid medicines (33.0%, 68/208) could be switched to tablet or capsule forms by pharmacist without any change to the prescribed dose. While for another 3.4% (7/208) long-term liquid medicines could be switched to solid dosage forms with prescriber approval, as prescribed doses would need to be adjusted slightly.ConclusionThe study highlights the extent of excipients exposure in children on long-term oral liquid medicines, many of which could potentially be harmful. Healthcare professionals should aim to reduce the long-term risks of excipients by providing an oral solid substitute to replace oral liquid formulation, where possible, and ensuring excipients are within safe, acceptable limits.ReferencesFabiano V, Mameli C, Zuccotti GV. Paediatric pharmacology: remember the excipients. Pharmacol Res 2011;63:362–365.Buckley L, Salunke S, Thompson K, et al. Challenges and strategies to facilitate formulation development of pediatric drug products: Safety qualification of excipients. Int J Pharm 2018; 536:563–569.

Comparison of regulatory dossier requirements for marketing authorization of generic solid dosage forms in the United States and Europe: A review

2021 ◽  
pp. 174113432110007
Author(s):  
Lovely Joylein ◽  
Bishop Adhikari ◽  
Megha Chellath Kottayi ◽  
GS Ravi ◽  
Akhilesh Dubey
Keyword(s):  
Generic Drug ◽  
Generic Drugs ◽  
The United States ◽  
Economic Benefits ◽  
Dosage Forms ◽  
Regulatory Requirements ◽  
Solid Dosage Forms ◽  
Drug Products ◽  
Solid Dosage ◽  
Pharmaceutical Manufacturers

Pharmaceutical solid dosage forms are categorized into several types based on the purpose, usage, and route of administration. Some examples of frequently available solid dosage forms include tablets, capsules, lozenges, powders, and granules. A generic drug is one of usually intending to be interchangeable with the innovator product, thereby making it essential for them to mimic the innovator drug concerning their safety and efficacy profiles. The essential concept of making a generic drug available hinges on its economic benefits towards the patient population as well as its feasibility in the development of benefits the pharmaceutical companies. Additionally, generic drugs expand the market of a particular API, thereby ensuring that an adequate number of medications are made available to cater to the needs of every patient and further preventing any issues arising out of drug shortages. The USFDA and the EMA, being two of the leading regulatory agencies across the globe, have long been associated with the development and drafting of regulations about the approval of generic drug products. A firm understanding of the regulatory requirements associated with the preparation of a generic drug dossier will aid pharmaceutical manufacturers in attaining favourable outcomes when desiring multicounty submissions, thereby ensuring a smooth review process without any substantial delays.

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

PHYSICO CHEMICAL EVALUATION OF AVIPATTIKARA CHURNA AND ITS DEVELOPED FORM OF SYRUP

INDIAN DRUGS ◽  
2015 ◽  
Vol 52 (06) ◽  
pp. 38-42
Author(s):  
G.G. Gadad ◽  
◽  
K. S. Gudaganatti ◽  
V.S. Mannur
Keyword(s):  
Dosage Form ◽  
Oral Route ◽  
Physicochemical Analysis ◽  
Dosage Forms ◽  
Solid Dosage ◽  
Chemical Evaluation ◽  
Physico Chemical ◽  
Limit Test ◽  
Loss Of Appetite ◽  
Liquid Dosage Form

Development and modification of Ayurvedic classical formulations into widely acceptable dosage forms is an important area to be focused in the present era. The designing of liquid dosage form has generally been emphasized on the basis of ease of administration to those individuals who have difficulty in swallowing solid dosage forms, specially in pediatric and geriatric group. Churna (powders) are the preferentially administered Ayurvedic formulations by oral route. Most of these powders are hygroscopic, bitter to taste and should be administered with suitable vehicle. Avipattikara Churna is one of the unique formulation widely practiced in the management of common ailments like Amlapitta (hyperacidity), Vibandha (constipation), Agnimandya (loss of appetite), Arsha (hemorrhoids). Modification of the classical Churna (solid dosage form) into a more acceptable and convenient syrup (liquid dosage form) with modern pharmaceutical methods and its physico-chemical analysis is the main aim of the study. In the present study Avipattikara syrup was developed with 66.7 % w/V of Khandasharkara (sugar candy powder) without any pharmaceutical additives. Physicochemical analysis, microbial limit test, and physical quality tests for Avipattikara Churna and syrup were carried out respectively. Results suggest that, the developed syrup had a quality of ideal syrup.

Isolation, Characterization, Chemical Modification and Application of Echinochloa Colona Starch as Tablet Disintegrant

2021 ◽  
Vol 14 (4) ◽  
pp. 5529-5537
Author(s):  
Sakhare Sfurti Shamling ◽  
Siddhi Chavan ◽  
Gurav Poonam Chandrakant ◽  
Rutuja Tanaji Kharat ◽  
Ajit Shankarao Kulkarni
Keyword(s):  
Chemical Modification ◽  
Dosage Form ◽  
Dosage Forms ◽  
Phytochemical Analysis ◽  
Solid Dosage Forms ◽  
Geriatric Population ◽  
Solid Dosage ◽  
Orally Disintegrating Tablets ◽  
Additional Water ◽  
Tablet Preparation

Oral disintegrating tablets are solid dosage form containing medical substances which disintegrate rapidly, usually within few seconds when placed upon tongue requiring no additional water to facilitate swallowing. Solid dosage forms that can be disintegrated, dissolved, or suspended by saliva in the mouth resulting in easy swallowing can provide significant benefits to the pediatric and geriatric population, as well as other patients who prefer the convenience of easily swallowable dosage forms Superdisintegrants are currently approached and utilized in the formulation of the orally disintegrating tablets. The present work includes isolation of starch from Echinochloa Colona and further characterizing it for various physicochemical and phytochemical analysis. The isolated starch has been modified chemically and its disintegrating efficiency has been tested in tablet formulation; the present work also explores the optimization of concentration of starch in formulation of Ibuprofen tablets in comparison with synthetic and natural superdisintegrants. Phytochemical analysis confirmed the presence of starches and carbohydrates. Results indicated that the Echinochloa Colona starch samples could be potential superdisintegrants in orally disintegrating tablets of Ibuprofen. Tablet performance was found to influence by the way of addition of starch, its concentration and the method of tablet preparation. From these results it is possible to conclude that Echinochloa Colona starch could be used as a superdisintegrant.

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.

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