scholarly journals Characterization and Evaluation of Capsules and Study of QC tests for Capsules

2018 ◽  
Vol III (I) ◽  
pp. 7-18
Author(s):  
Fahad Pervaiz ◽  
Sana Ali Zahra ◽  
Fariah Qaiser ◽  
Syeda Komal Fatima ◽  
Rabbia Mazhar Khan
Keyword(s):  
Pharmaceutical Industry ◽  
Drug Development ◽  
Clinical Outcomes ◽  
Dosage Form ◽  
Drug Product ◽  
Dynamic Change ◽  
Dosage Forms ◽  
Preparation Process ◽  
Efficacy And Safety ◽  
Pharmaceutical Industries

Using the capsule as a dosage form dates back to the early pharmacy days; from those days, the capsule preparation process is greatly evolved in order to meet the current needs of patients and the pharmaceutical industry. Currently, all pharmaceutical industries are making a dynamic change in the specifications of particular dosage forms such as capsules. It has become more difficult to obtain the higher valued drug product from the dosage form, along with the potential for improved delivery that can improve clinical outcomes. In addition, the capsules have played a significant role in drug development because of the hand filling or the production of semiautomatic capsular formulations, which have fewer requirements, and can be developed easily. The article will discuss different tests like Universal tests and specific tests, particularly for capsules, performed prior to the release of the batch to ensure efficacy and safety.

Development of Innovative Orally Fast Disintegrating Film Dosage Forms: A Review

2012 ◽  
Vol 5 (2) ◽  
pp. 1666-1674 ◽  
Author(s):  
Bibhu Prasad Panda ◽  
N.S Dey ◽  
M.E.B. Rao
Keyword(s):  
Drug Delivery ◽  
Drug Delivery Systems ◽  
Dosage Form ◽  
Geriatric Patients ◽  
Dosage Forms ◽  
Delivery Systems ◽  
Design And Development ◽  
Innovative Drug ◽  
Potential Benefits ◽  
Pharmaceutical Industries

Over the past few decades, there has been an increased interest for innovative drug delivery systems to improve safety, efficacy and patient compliance, thereby increasing the product patent life cycle. The discovery and development of new chemical entities is not only an expensive but also time consuming affair. Hence the pharmaceutical industries are focusing on the design and development of innovative drug delivery systems for existing drugs. One such delivery system is the fast disintegrating oral film, which has gained popularity among pediatric and geriatric patients. This fast disintegrating film with many potential benefits of a fast disintegrating tablet but devoid of friability and risk of choking is more acceptable to pediatric and geriatric patients. Formulation of fast disintegrating film can be achieved by various techniques, but common methods of preparation include spraying and casting. These film forming techniques use hydrophilic film former in combination with suitable excipients, which allow the film to disintegrate or dissolve quickly in the mouth within a few seconds without the administration of water. In view of the advantages of the fast disintegrating films over the fast disintegrating tablets and other dosage forms, it has the potential for commercial exploitation. The oral film dosage form not only has certain advantages of other fast disintegrating systems but also satisfies the unmet needs of the market. The present review emphasizes on the potential benefits, design and development of robust, stable, and innovative orally fast- disintegrating films and their future scenarios on a global market as a pharmaceutical dosage form.  

Orphan drugs: trends and issues in drug development

2018 ◽  
Vol 29 (5) ◽  
pp. 437-446 ◽  
Author(s):  
Proteesh Rana ◽  
Shalini Chawla
Keyword(s):  
Pharmaceutical Industry ◽  
Drug Development ◽  
Orphan Drug ◽  
Rare Diseases ◽  
Drug Market ◽  
Medical Needs ◽  
Common Diseases ◽  
Pharmaceutical Industries ◽  
The Government ◽  
Orphan Drug Development

Abstract Research in rare diseases has contributed substantially toward the current understanding in the pathophysiology of the common diseases. However, medical needs of patients with rare diseases have always been neglected by the society and pharmaceutical industries based on their small numbers and unprofitability. The Orphan Drug Act (1983) was the first serious attempt to address the unmet medical needs for patients with rare diseases and to provide impetus for the pharmaceutical industry to promote orphan drug development. The process of drug development for rare diseases is no different from common diseases but involves significant cost and infrastructure. Further, certain aspect of drug research may not be feasible for the rare diseases. The drug-approving authority must exercise their scientific judgment and ensure due flexibility while evaluating data at various stages of orphan drug development. The emergence of patent cliff combined with the government incentives led the pharmaceutical industry to realize the good commercial prospects in developing an orphan drug despite the small market size. Indeed, many drugs that were given orphan designation ended up being blockbusters. The orphan drug market is projected to reach $178 billion by 2020, and the prospects of research and development in rare diseases appears to be quite promising and rewarding.

scholarly journals The Association for Human Pharmacology in the Pharmaceutical Industry London Meeting October 2019: Impending Change, Innovation, and Future Challenges

2020 ◽  
Vol 11 ◽  
Author(s):  
Shahzadgai Khan ◽  
Muna Albayaty ◽  
James Bush ◽  
Joseph Cheriyan ◽  
Anthea Cromie ◽  
...  
Keyword(s):  
Pharmaceutical Industry ◽  
Drug Development ◽  
Drug Product ◽  
Pharmaceutical Medicine ◽  
Pharmacokinetic Modeling ◽  
Oral Dosage ◽  
Afternoon Session ◽  
Clinical Drug Development ◽  
Human Pharmacology ◽  
Future Challenges

The Association for Human Pharmacology in the Pharmaceutical Industry (AHPPI) annual meeting focused on impending change, innovation, and future challenges facing early phase drug development as we move into the second decade of the 21th century. The meeting opened with discussion around the technical revolution in pharmaceutical medicine over the 4 decades since the AHPPI was founded and how transformative technologies have accompanied the introduction of processes such as physiologically based pharmacokinetic modeling. During the meeting examples were presented of how in terms of the development of new therapies, the classic phases of clinical drug development are becoming a thing of the past and the lines between the phases have begun to blur, particularly in the field of oncology. The contribution that monoclonal antibodies have made to medicine and the next chapter in their design and use was also discussed. A representative of the UK’s Medicine and Healthcare Products Regulatory Agency discussed the increasing numbers of requests to approve complex innovative design trials, how novel trial designs are impacting on the traditional linear “phase” approach to drug development and the common pitfalls associated with them. Guidance was provided from a regulator’s viewpoint on what was meant by the term “novel design” and how to submit successful trial applications for such complex trials. In an Oxford-style debate, the audience discussed the motion that “there is no longer a need to include placebo subjects in early clinical trials.” The keynote speaker focused on delivering change in complex environments such as the field of drug development. The afternoon session included presentations on the challenges associated with drug product design, the complexities within non-oral dosage forms and proposed new methods of formulations for drug delivery. Presentations were also given on advances in mechanistic and computational pharmacokinetic modeling and how they have proved to be valuable tools to rationalize and facilitate the process of drug development.

Spectrophotometric Determination of Alendronate Sodium by using Sodium-1,2-Naphthoquinone-4-Sulphonate

2012 ◽  
Vol 4 (4) ◽  
pp. 1563-1568
Author(s):  
Sagar Suman Panda ◽  
Ravi Kumar B V V ◽  
D Patanaik
Keyword(s):  
Spectrophotometric Method ◽  
Absorption Maximum ◽  
Dosage Form ◽  
Dosage Forms ◽  
Alendronate Sodium ◽  
Colored Complex ◽  
Pharmaceutical Dosage Forms ◽  
Recovery Study ◽  
Assay Conditions

A simple, precise and accurate spectrophotometric method was developed for analysis of the osteoporesis drug alendronate sodium (ALS). The method is based on reaction of the drug with sodium-1,2-naphthoquinone-4-sulphonate (NQS) in presence of alkali to form a brown colored complex giving absorption maximum at 525 nm. The drug obeyed Beer’s law in the range of 5-70 µg/ml with a correlation coefficient of 0.999. The LOD and LOQ values are 1.7 µg/ml and 5.0 µg/ml, respectively. The average recoveries for recovery study were found to be in the range of 99.37%-100.46%. The R.S.D. values for intraday and inter-day precision were found to be 0.48 and 0.62, respectively. The optimized assay conditions were applied successfully for determination of ALS in pharmaceutical dosage forms. No interference was observed from the excipients present in the dosage form. The method is statistically validated as per the ICH requirements.  

An Overview of Excipients Classification and Their Use in Pharmaceuticals

2020 ◽  
Vol 16 ◽  
Author(s):  
Cansel Kose Ozkan ◽  
Ozgur Esim ◽  
Ayhan Savaser ◽  
Yalcin Ozkan
Keyword(s):  
Drug Delivery ◽  
Drug Delivery Systems ◽  
Dosage Form ◽  
Dosage Forms ◽  
Design Development ◽  
Pharmaceutical Dosage Form ◽  
Pharmaceutical Dosage Forms ◽  
Product Identification ◽  
Direct Administration ◽  
Active Substances

: The content and the application of pharmaceutical dosage forms must meet several basic requirements to ensure and maintain efficiency, safety and quality. A large number of active substances have limited ability to direct administration. Excipients are generally used to overcome the limitation of direct administration of these active substances. However, the function, behavior and composition of the excipients need to be well known in the design, development and production of pharmaceutical dosage forms. In this review, excipients used to assist in any pharmaceutical dosage form production processes of drugs, to preserve, promote or increase stability, bioavailability and patient compliance, to assist in product identification / separation, or to enhance overall safety and effectiveness of the drug delivery system during storage or use are explained. Moreover, the use of these excipients in drug delivery systems are identified. Excipient toxicity, which is an issue discussed in the light of current studies, also discussed in this review.

Determining the structure of pharmaceutical industry in Iran

2019 ◽  
Vol 13 (1) ◽  
pp. 101-115
Author(s):  
Sara Emamgholipour ◽  
Lotfali Agheli
Keyword(s):  
Pharmaceutical Industry ◽  
Economies Of Scale ◽  
Monopolistic Competition ◽  
Pharmaceutical Market ◽  
Data Availability ◽  
Market Demand ◽  
Firm Level ◽  
Content Type ◽  
Measure Concentration ◽  
Pharmaceutical Industries

Purpose As the pharmaceutical industry is one of the key sectors of the health-care system, the identification of its structure is of particular importance. This paper aims to determine the structure of the pharmaceutical industry in Iran to provide appropriate solutions for pricing and regulation by policymakers. Iran is a growing pharmaceutical market with over $4bn in sales, so the supply side needs to be examined to meet the domestic consumption. Design/methodology/approach This research is a descriptive and retrospective analytical study which examines the Iranian pharmaceutical industry through library studies and using pharmaceutical data of the country’s Food and Drug Administration during 1992-2016. Due to data availability in firm level, the concentration ratio of N leading firms and the Herfindahl–Hirschman index are used to measure the concentration of the pharmaceutical market in 2014 and 2016. Findings The results show that pharmaceutical manufacturing, importing companies and distributing companies play roles in monopolistic competition market, loose oligopoly market and oligopoly market, respectively. For all companies, the magnitudes of Herfindahl–Hirschman indices indicate non-competitive settings. As a result, these companies set their own prices, and market demand affects their sales. In addition, demand for medicines is shaped in the form of supply-induced demand. Research limitations/implications This research was accomplished with no computational limitation. However, it was confined to only one country, one industry and the mentioned period of study. Practical implications The pharmaceutical manufacturers have no influence on medicine prices, and government pricing regulations lessen the market power of such market agents. However, the easy entry to and exit from market stimulate producers to participate in manufacturing activities. The pharmaceutical importers may expand their imports in response to entry new actors; however, the new entrants weaken the coordination on pricing decisions. Social implications As pharmaceutical distributers act in an oligopoly market, they can collude, reduce competition and lower the welfare of pharmaceutical consumers. In such conditions, high investment requirements and economies of scale may discourage the entry of new firms. Originality/value Although there are various studies on market structure in non-pharmaceutical industries, this study is a new effort to measure concentration in the Iranian pharmaceutical market and to determine its structure.

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 A REVIEW: ANTI-CANCER NATURAL PRODUCT DRUG DELIVERY SYSTEM DOSAGE FORM AND EVALUATION

2021 ◽  
pp. 41-51
Author(s):  
RIZKA KHOIRUNNISA GUNTINA ◽  
IYAN SOPYAN ◽  
ADE ZUHROTUN
Keyword(s):  
Drug Delivery ◽  
Natural Product ◽  
Drug Delivery System ◽  
Delivery System ◽  
Dosage Form ◽  
Dosage Forms ◽  
Primary Data ◽  
Pharmaceutical Dosage Form ◽  
New Drug

A drug delivery system is a system in which a drug is released from a pharmaceutical dosage form to achieve the desired pharmacological effect. The system consists of conventional and new drug delivery systems. In the new drug delivery system, polymers are used as a matrix. The aim of this article is to find out and understand the formulation and evaluation of natural ingredients that have anticancer activity with different dosage forms and the basis for developing these dosages. Journal searches in this review came from primary data sources on the internet. Journal searches were carried out using a search engine such as Google Scholar, PubMed, and ScienceDirect. In recent years, natural products, such as extract, fraction, and isolate, are getting attention to help treat cancer. Because of their low solubility and bioavailability, the effectiveness tends to be lower than synthetic drugs. Therefore, a dosage form with a new drug delivery system was made to overcome the problem. The dosage forms commonly made are patch, suspension, powder, and emulsion with a new drug delivery system. To ensure the product that has been made met the requirements, they need to be evaluated with various methods like In vitro Study, morphology study, particle size study, and others. Cancer treatment using the natural product can be delivered through several dosage forms like patch, suspension, powder, and emulsion, with specific formulation and manufacturing methods based on several considerations such as natural ingredients properties, dosage form selection, excipient properties, and the purpose of the formulation. Dosage forms that has been made are then evaluated using several evaluation methods.

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