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PloS One 2018The Semi-solid Control Diagram (SSCD) is a new tool designed for the study of different excipients and different semi-solid dosage forms. It can be used to review and...
The Semi-solid Control Diagram (SSCD) is a new tool designed for the study of different excipients and different semi-solid dosage forms. It can be used to review and evaluate different formulations and/or batches and facilitate the selection of one of them that will present the most suitable galenic characteristics for topical application. It is also useful to track stability studies by comparing the diagrams, which allows to measure the impact of subjecting the formulation to different conditions and times to be examined. In this study, the Semi-solid Control Diagram (SSCD) is used as an instrument for studying and evaluating semi-solid pharmaceutical dosage forms, by comparing several different semisolid preparations (lipogels). With these results, the tool is validated and the best formulation has been discriminated from the others.
Topics: Algorithms; Dosage Forms; Drug Compounding; Drug Stability; Excipients; Pharmaceutical Preparations; Technology, Pharmaceutical
PubMed: 30192759
DOI: 10.1371/journal.pone.0201643 -
Acta Poloniae Pharmaceutica 2012In the recent years, there is a growing interest in the lipid-based formulations for delivery of lipophilic drugs. Due to their potential as therapeutic agents,... (Review)
Review
In the recent years, there is a growing interest in the lipid-based formulations for delivery of lipophilic drugs. Due to their potential as therapeutic agents, preferably these lipid soluble drugs are incorporated into inert lipid carriers such as oils, surfactant dispersions, emulsions, liposomes etc. Among them, emulsion forming drug delivery systems appear to be a unique and industrially feasible approach to overcome the problem of low oral bioavailability associated with the BCS class II drugs. Self-emulsifying formulations are ideally isotropic mixtures of oils, surfactants and co-solvents that emulsify to form fine oil in water emulsions when introduced in aqueous media. Fine oil droplets would pass rapidly from stomach and promote wide distribution of drug throughout the GI tract, thereby overcome the slow dissolution step typically observed with solid dosage forms. Recent advances in drug carrier technologies have promulgated the development of novel drug carriers such as control release self-emulsifying pellets, microspheres, tablets, capsules etc. that have boosted the use of "self-emulsification" in drug delivery. This article reviews the different types of formulations and excipients used in emulsion forming drug delivery system to enhance the bioavailability of lipophilic drugs.
Topics: Chemistry, Pharmaceutical; Drug Delivery Systems; Emulsions; Excipients; Solubility
PubMed: 22568032
DOI: No ID Found -
British Medical Journal Apr 1967
Topics: Adrenocorticotropic Hormone; Chemical Phenomena; Chemistry; Costs and Cost Analysis; Dosage Forms; Humans; United Kingdom
PubMed: 4290032
DOI: No ID Found -
Journal of Pharmacy & Pharmaceutical... 2010Despite advances in technology, drug discovery is still a lengthy, expensive, difficult, and inefficient process, with a low rate of success. Today, advances in... (Review)
Review
Despite advances in technology, drug discovery is still a lengthy, expensive, difficult, and inefficient process, with a low rate of success. Today, advances in biomedical science have brought about great strides in therapeutic interventions for a wide spectrum of diseases. The advent of biochemical techniques and cutting-edge bio/chemical technologies has made available a plethora of practical approaches to drug screening and design. In 2010, the total sales of the global pharmaceutical market will reach 600 billion US dollars and expand to over 975 billion dollars by 2013. The aim of this review is to summarize available information on contemporary approaches and strategies in the discovery of novel therapeutic agents, especially from the complementary and alternative medicines, including natural products and traditional remedies such as Chinese herbal medicine.
Topics: Biological Products; Dosage Forms; Drug Design; Drug Discovery; Drugs, Chinese Herbal; Humans; Pharmaceutical Preparations
PubMed: 21092716
DOI: 10.18433/j39w2g -
AAPS PharmSciTech Oct 2005The purpose of writing this review on floating drug delivery systems (FDDS) was to compile the recent literature with special focus on the principal mechanism of... (Review)
Review
The purpose of writing this review on floating drug delivery systems (FDDS) was to compile the recent literature with special focus on the principal mechanism of floatation to achieve gastric retention. The recent developments of FDDS including the physiological and formulation variables affecting gastric retention, approaches to design single-unit and multiple-unit floating systems, and their classification and formulation aspects are covered in detail. This review also summarizes the in vitro techniques, in vivo studies to evaluate the performance and application of floating systems, and applications of these systems. These systems are useful to several problems encountered during the development of a pharmaceutical dosage form.
Topics: Animals; Dosage Forms; Drug Carriers; Drug Delivery Systems; Gastrointestinal Agents; Gastrointestinal Tract; Humans; Pharmaceutical Preparations
PubMed: 16353995
DOI: 10.1208/pt060347 -
The AAPS Journal Sep 2005Drugs have been compounded for veterinary practice for many years because it has been necessary in the course of routine practice. However, regulations and compliance... (Review)
Review
Drugs have been compounded for veterinary practice for many years because it has been necessary in the course of routine practice. However, regulations and compliance policy guidelines (CPGs) should be recognized. A new CPG issued in July 2003 listed the current Food and Drug Administration (FDA) limitations on compounding for veterinary medicine. To summarize the guideline: drugs must not be compounded from bulk substances, and the compounding must not constitute manufacture of a new animal drug. Drug compounding on a case-by-case basis is allowed under the CPG. However, veterinarians and pharmacists must be aware of potential incompatibilities and practices that may interfere with the drug's stability, purity, and/or potency.
Topics: Animals; Dosage Forms; Drug Compounding; Drug Stability; Veterinarians; Veterinary Medicine
PubMed: 16353910
DOI: 10.1208/aapsj070229 -
JAMA Network Open Aug 2020Health care practitioners and patients must have information to support their confidence in the quality of prescription pharmaceuticals.
IMPORTANCE
Health care practitioners and patients must have information to support their confidence in the quality of prescription pharmaceuticals.
OBJECTIVE
To determine whether there were clear and substantive differences in major quality attributes between difficult-to-make solid oral dosage form pharmaceutical products marketed in the US.
DESIGN, SETTING, AND PARTICIPANTS
This quality improvement study analyzed US Food and Drug Administration-collected samples of 252 drug products marketed in the US and manufactured in the US, Canada, Europe, India, and the rest of Asia. These drug products were immediate-release solid oral dosage forms considered difficult to make on the basis of product quality history. This sampling included 35 innovator and 217 generic drug samples manufactured by 46 different firms containing 17 different active ingredients. Statistical analysis was performed from February to November 2019.
MAIN OUTCOMES AND MEASURES
All products were tested within their shelf life on the basis of the legally recognized tests of the US Pharmacopeia for the major quality attributes of dosage unit uniformity and dissolution. These tests measure dosage consistency and drug release, respectively. The consistency of either attribute was used to calculate a process performance index to describe the variability in manufacturing.
RESULTS
All 252 drug product samples met the US market standards for dosage unit uniformity and dissolution, although the process performance index (Ppk) for dissolution fell below the level of 4-sigma capability (ie, <1 error per 1600) for 11 different manufacturers and for generics in 4 of 5 regions, including the US. As part of a retrospective analysis, manufacturers performing above the median Ppk for either dissolution or dosage unit uniformity submitted fewer product quality defect reports (mean field alert reports of 0.22 and 0.63, respectively) than those falling at or below the median Ppk for these attributes (mean field alert reports of 2.1 and 1.7, respectively).
CONCLUSIONS AND RELEVANCE
All samples met the US market standards for dosage unit uniformity and dissolution, indicating acceptability for use by patients regardless of manufacturer or region. To our knowledge, this is the largest sampling study of pharmaceutical manufacturers for the US market and these data provide objective insight into the quality of prescription drugs with high manufacturing risks.
Topics: Capsules; Drugs, Generic; Pharmaceutical Preparations; Quality Control; Quality Improvement; Tablets; United States
PubMed: 32833019
DOI: 10.1001/jamanetworkopen.2020.13920 -
The Journal of Pharmacy and Pharmacology Apr 2017The aim of this review was to map the currently available evidence on acceptability of oral paediatric medicines to aid in the selection of suitable platform... (Review)
Review
OBJECTIVES
The aim of this review was to map the currently available evidence on acceptability of oral paediatric medicines to aid in the selection of suitable platform formulations for the development of new acceptable paediatric products.
METHODS
This process used a defined search strategy of indexed publications and included methods to assess the quality of the evidence retrieved.
KEY FINDINGS
Taste/palatability was the most extensively studied area of paediatric medicine acceptability yet standard methods or criteria that define what is classed as acceptable to children is still to be defined. There have been many reports on the acceptability of medicines to paediatric populations yet major gaps in the acceptability knowledge base exist including the shape and dimensions of tablets, minitablets and capsules swallowed whole in infants and children; size and overall volume of multiparticulates; volume of liquids completely swallowed in infants and children; duration of retention within the oral cavity, size and taste of orodispersible tablets, lozenges and chewable tablets and the number of solid units dosed at each time point.
CONCLUSIONS
The review highlights where further information is required to support knowledge around acceptability of age-appropriate medicines. An algorithm to aid in selection of a formulation that is likely to be acceptable based on the age range to be treated by the medicine is presented as a result of this review.
Topics: Administration, Oral; Child; Child, Preschool; Deglutition; Dosage Forms; Drug Compounding; Humans; Infant; Pharmaceutical Preparations; Tablets; Taste
PubMed: 27524471
DOI: 10.1111/jphp.12610 -
Journal of Pharmacy & Pharmaceutical... 2017The rising population with grave ramifications for the future is a fundamental issue, demanding for newer and better contraceptive modalities. Also, in order to achieve... (Review)
Review
The rising population with grave ramifications for the future is a fundamental issue, demanding for newer and better contraceptive modalities. Also, in order to achieve the contraceptive purpose, the choice of the most suitable delivery system is of unquestionable importance. Out of all dosage forms, vaginal gel formulations present indubitable benefits for contraceptive administration. Therefore, this review summarizes the history of research in the field of vaginal delivery systems with special emphasis on the development of vaginal gels containing safer and more effective contraceptive agents. This article is open to POST-PUBLICATION REVIEW. Registered readers (see "For Readers") may comment by clicking on ABSTRACT on the issue's contents page.
Topics: Administration, Intravaginal; Chemistry, Pharmaceutical; Drug Delivery Systems; Gels; Humans
PubMed: 28810947
DOI: 10.18433/J3FM06 -
International Journal of Pharmaceutics Oct 2022Three-dimensional (3D) printing is becoming an attractive technology for the design and development of personalized paediatric dosage forms with improved palatability....
Three-dimensional (3D) printing is becoming an attractive technology for the design and development of personalized paediatric dosage forms with improved palatability. In this work micro-extrusion based printing was implemented for the fabrication of chewable paediatric ibuprofen (IBU) tablets by assessing a range of front runner polymers in taste masking. Due to the drug-polymer miscibility and the IBU plasticization effect, micro-extrusion was proved to be an ideal technology for processing the drug/polymer powder blends for the printing of paediatric dosage forms. The printed tablets presented high printing quality with reproducible layer thickness and a smooth surface. Due to the drug-polymer interactions induced during printing processing, IBU was found to form a glass solution confirmed by differential calorimetry (DSC) while H-bonding interactions were identified by confocal Raman mapping. IBU was also found to be uniformly distributed within the polymer matrices at molecular level. The tablet palatability was assessed by panellists and revealed excellent taste masking of the IBU's bitter taste. Overall micro-extrusion demonstrated promising processing capabilities of powder blends for rapid printing and development of personalised dosage forms.
Topics: Child; Drug Liberation; Excipients; Humans; Ibuprofen; Polymers; Powders; Printing, Three-Dimensional; Tablets; Technology, Pharmaceutical
PubMed: 36028083
DOI: 10.1016/j.ijpharm.2022.122135