Extemporaneously prepared controlled release formulations for accelerating the early phase development of drug candidates

Thombre, Avinash G.; Berchielli, Alfred; Rogers, Janyce F.

doi:10.1016/j.drudis.2014.02.001

Cited by 16 publications

(3 citation statements)

References 22 publications

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“…DA is an indispensable practice in hospitals because many patients often have specific needs that require the administration of drugs in various dosage forms (Haywood, Glass, 2013;Thombre, Berchielli, Rogers, 2014).…”

Section: Discussionmentioning

confidence: 99%

“…The lack of liquid pharmaceutical forms for oral use on the market has become a problem for the pharmacotherapy of patients that primarily uses liquid formulations, such as pediatric patients, the elderly, patients receiving drugs via probe, patients with dysphagia, and patients with dementias, Parkinson's, or Alzheimer's disease (Haywood, Glass, 2013;Thombre, Berchielli, Rogers, 2014). Patients with these problems require extemporaneous oral preparations in order to ensure the patient's therapy.…”

Section: Introductionmentioning

confidence: 99%

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Analysis of extemporaneous oral liquid from commercially available drugs in hospital

Benzi

Mastroianni

2016

Braz. J. Pharm. Sci.

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The objective of this study was to identify drugs that received dose adjustments (DA) and pharmaceutical alternatives (PA) that avoid DA, and calculate the economic percentage of this replacement. A descriptive, observational and cross-sectional study was performed in a second level hospital. The pharmacy and nursing services was accompanied to identify the drugs that received DA and the compounding techniques. After identifying all the drugs that received DA, was identified in the Brazilian market the corresponding pharmaceutical alternative, with the Drugs Price List of Brazilian Health Regulatory Agency. For those drugs that was not available any PA, was performed a research of studies that describe compounding techniques in international scientific databases. Was identify 88 drugs that received DA, and these, 50 do not have any PA. Were identified compounding techniques to 40 drugs. Although any drug has your own particularity of compounding, the compounding techniques can be grouped in five categories. The standardization of 29 drugs can reduce in 28% the DA procedure and cost saving of 34,85%/month. We can conclude that every three drugs prescribed, one received DA and every three DA, one can be avoided by the selection of 29 PA, saving cost as well. The use and standardization of five techniques would attend the pharmaceutics recommendations for better dissolution, bioavailability and patient safety. Uniterms:Pharmaceutical preparations/hospitals. Patient safety. Pharmacoeconomics. Drugs/descritive study/ Off-Label Use. INTRODUCTIONDose adjustment (DA) is performed to supply a patient's therapeutic needs when non-standard dosages are needed (Brasil, 2007; FDA, 2013). The lack of liquid pharmaceutical forms for oral use on the market has become a problem for the pharmacotherapy of patients that primarily uses liquid formulations, such as pediatric patients, the elderly, patients receiving drugs via probe, patients with dysphagia, and patients with dementias, Parkinson's, or Alzheimer's disease (Haywood, Glass, 2013;Thombre, Berchielli, Rogers, 2014). Patients with these problems require extemporaneous oral preparations in order to ensure the patient's therapy. DA is common in health systems; however, there are no guarantees regarding the quality, effectiveness, and safety of drugs after DA and DA can expose the patient to adverse events (Glass, Haywood, 2006).With the aim of ensuring the pharmacotherapy of the patient, contributing to the culture of patient safety, and objectively identifying drugs that underwent DA and pharmaceutical alternatives (PAs) that could avoid DA, we compared DA to the compounding techniques described in the literature and calculated the economy of PAs. METHODS Study designThis was a pharmaco-epidemiological, descriptive, and observational cross-sectional study based on the guideline Strengthening the Reporting of Observational studies in Epidemiology (STROBE) (Von Elm et al., 2008). Study siteThis study was conducted at the State Hospital Américo Brasiliense (HEAB) in Américo Br...

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Analysis of extemporaneous oral liquid from commercially available drugs in hospital

Benzi

Mastroianni

2016

Braz. J. Pharm. Sci.

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“…Alternatively, neat drug candidate or simple dry blends can be supplied in a capsule or compounded into tablets for compression in a clinical pharmacy. Controlled release formulations can also be extemporaneously prepared in the clinical setting where necessary and can significantly speed up early clinical development [61].…”

Section: Early Clinical Formulation Developmentmentioning

confidence: 99%

Commentary: Why Pharmaceutical Scientists in Early Drug Discovery Are Critical for Influencing the Design and Selection of Optimal Drug Candidates

2017

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Abstract. This commentary reflects the collective view of pharmaceutical scientists from four different organizations with extensive experience in the field of drug discovery support. Herein, engaging discussion is presented on the current and future approaches for the selection of the most optimal and developable drug candidates. Over the past two decades, developability assessment programs have been implemented with the intention of improving physicochemical and metabolic properties. However, the complexity of both new drug targets and non-traditional drug candidates provides continuing challenges for developing formulations for optimal drug delivery. The need for more enabled technologies to deliver drug candidates has necessitated an even more active role for pharmaceutical scientists to influence many key molecular parameters during compound optimization and selection. This enhanced role begins at the early in vitro screening stages, where key learnings regarding the interplay of molecular structure and pharmaceutical property relationships can be derived. Performance of the drug candidates in formulations intended to support key in vivo studies provides important information on chemotype-formulation compatibility relationships. Structure modifications to support the selection of the solid form are also important to consider, and predictive in silico models are being rapidly developed in this area. Ultimately, the role of pharmaceutical scientists in drug discovery now extends beyond rapid solubility screening, early form assessment, and data delivery. This multidisciplinary role has evolved to include the practice of proactively taking part in the molecular design to better align solid form and formulation requirements to enhance developability potential.

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Industry Perspectives for the Evaluation of MR Formulations

Tomaszewska¹,

McAllister²

2022

Oral Drug Delivery for Modified Release Formulations

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Extemporaneously prepared controlled release formulations for accelerating the early phase development of drug candidates

Cited by 16 publications

References 22 publications

Analysis of extemporaneous oral liquid from commercially available drugs in hospital

Analysis of extemporaneous oral liquid from commercially available drugs in hospital

Commentary: Why Pharmaceutical Scientists in Early Drug Discovery Are Critical for Influencing the Design and Selection of Optimal Drug Candidates

Industry Perspectives for the Evaluation of MR Formulations

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