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At least 19 records
All sourcesNASA NTRSDOE OSTI
NASA NTRS2016

Pharmaceuticals Exposed to the Space Environment: Problems and Prospects

The NASA Human Research Program (HRP) Health Countermeasures Element maintains ongoing efforts to inform detailed risks, gaps, and further questions associated with the use of pharmaceuticals in space. Most recently, the Pharmacology Risk Report, released in 2010, illustrates the problems associated with maintaining pharmaceutical efficacy. Since the report, one key publication includes evaluation of pharmaceutical products stored on the International Space Station (ISS). This study shows that selected pharmaceuticals on ISS have a shorter shelf-life in space than corresponding terrestrial controls. The HRP Human Research Roadmap for planetary exploration identifies the risk of ineffective or toxic medications due to long-term storage during missions to Mars. The roadmap also identifies the need to understand and predict how pharmaceuticals will behave when exposed to radiation for long durations. Terrestrial studies of returned samples offer a start for predictive modeling. This paper shows that pharmaceuticals returned to Earth for post-flight analyses are amenable to a Weibull distribution analysis in order to support probabilistic risk assessment modeling. The paper also considers the prospect of passive payloads of key pharmaceuticals on sample return missions outside of Earth's magnetic field to gather additional statistics. Ongoing work in radiation chemistry suggests possible mitigation strategies where future work could be done at cryogenic temperatures to explore methods for preserving the strength of pharmaceuticals in the space radiation environment, perhaps one day leading to an architecture where pharmaceuticals are cached on the Martian surface and preserved cryogenically.

pharmacology↗
NASA NTRS2009

Stability of Dosage Forms in the Pharmaceutical Payload Aboard Space Missions

Efficacious pharmaceuticals with adequate shelf lives are essential for successful space medical operations. Stability of pharmaceuticals, therefore, is of paramount importance for assuring the health and wellness of astronauts on future space exploration missions. Unique physical and environmental factors of space missions may contribute to the instability of pharmaceuticals, e.g., radiation, humidity and temperature variations. Degradation of pharmaceutical formulations can result in inadequate efficacy and/or untoward toxic effects, which could compromise astronaut safety and health. Methods: Four identical pharmaceutical payload kits containing 31 medications in different dosage forms (liquid, tablet, capsule, ointment and suppository) were transported to the International Space Station aboard the Space Shuttle (STS-121). One of the 4 kits was stored on the Shuttle and the other 3 were stored on the International Space Station (ISS) for return to Earth at 6-month interval aboard a pre-designated Shuttle flight for each kit. The kit stored on the Shuttle was returned to Earth aboard STS-121 and 2 kits from ISS were returned on STS 117 and STS-122. Results: Analysis of standard physical and chemical parameters of degradation was completed for pharmaceuticals returned by STS-121 after14 days, STS - 117 after11 months and STS 122 after 19 months storage aboard ISS. Analysis of all flight samples along with ground-based matching controls was completed and results were compiled. Conclusion: Evaluation of results from the shuttle (1) and ISS increments (2) indicate that the number of formulations degraded in space increased with duration of storage in space and was higher in space compared to their ground-based counterparts. Rate of degradation for some of the formulations tested was faster in space than on Earth. Additionally, some of the formulations included in the medical kits were unstable, more so in space than on the ground. These results indicate that the space flight environment may adversely affect the shelf life of pharmaceuticals aboard space missions.

Du, Brian J.↗
NASA NTRS2008

Stability of Formulations Contained in the Pharmaceutical Payload Aboard Space Missions

Efficacious pharmaceuticals with adequate shelf life are essential for successful space medical operations in support of space exploration missions. Physical and environmental factors unique to space missions such as vibration, G forces and ionizing radiation may adversely affect stability of pharmaceuticals intended for standard care of astronauts aboard space missions. Stable pharmaceuticals, therefore, are of paramount importance for assuring health and wellness of astronauts in space. Preliminary examination of stability of formulations from Shuttle and International Space Station (ISS) medical kits revealed that some of these medications showed physical and chemical degradation after flight raising concern of reduced therapeutic effectiveness with these medications in space. A research payload experiment was conducted with a select set of formulations stowed aboard a shuttle flight and on ISS. The payload consisted of four identical pharmaceutical kits containing 31 medications in different dosage forms that were transported to the International Space Station (ISS) aboard the Space Shuttle, STS 121. One of the four kits was stored on the shuttle and the other three were stored on the ISS for return to Earth at six months intervals on a pre-designated Shuttle flight for each kit; the shuttle kit was returned to Earth on the same flight. Standard stability indicating physical and chemical parameters were measured for all pharmaceuticals returned from the shuttle and from the first ISS increment payload along with ground-based matching controls. Results were compared between shuttle, ISS and ground controls. Evaluation of data from the three paradigms indicates that some of the formulations exhibited significant degradation in space compared to respective ground controls; a few formulations were unstable both on the ground and in space. An increase in the number of pharmaceuticals from ISS failing USP standards was noticed compared to those from the shuttle flight. A comprehensive evaluation of results is in progress.

Putcha, Lakshmi↗
NASA NTRS2011

Application of Emerging Pharmaceutical Technologies for Therapeutic Challenges of Space Exploration Missions

An important requirement of therapeutics for extended duration exploration missions beyond low Earth orbit will be the development of pharmaceutical technologies suitable for sustained and preventive health care in remote and adverse environmental conditions. Availability of sustained, stable and targeted delivery pharmaceuticals for preventive health of major organ systems including gastrointestinal, hepato-renal, musculo-skeletal and immune function are essential to offset adverse effects of space environment beyond low Earth orbit. Specifically, medical needs may include multi-drug combinations for hormone replacement, radiation protection, immune enhancement and organ function restoration. Additionally, extended stability of pharmaceuticals dispensed in space must be also considered in future drug development. Emerging technologies that can deliver stable and multi-therapy pharmaceutical preparations and delivery systems include nanotechnology based drug delivery platforms, targeted-delivery systems in non-oral and non-parenteral formulation matrices. Synthetic nanomaterials designed with molecular precision offer defined structures, electronics, and chemistries to be efficient drug carriers with clear advantages over conventional materials of drug delivery matricies. Nano-carrier materials like the bottle brush polymers may be suitable for systemic delivery of drug cocktails while Superparamagnetic Iron Oxide Nanoparticles or (SPIONS) have great potential to serve as carriers for targeted drug delivery to a specific site. These and other emerging concepts of drug delivery and extended shelf-life technologies will be reviewed in light of their application to address health-care challenges of exploration missions. Innovations in alternate treatments for sustained immune enhancement and infection control will be also discussed.

Putcha, Lakshmi↗
NASA NTRS2023

Bacillus Subtilis Engineered for Aerospace Medicine: A Platform for Off-Planet Production of Pharmaceutical Peptides

Biologics, such as pharmaceutical peptides, have notoriously short shelf lives, insufficient for long-duration space flight missions to the Moon or Mars. To enable the sustainable presence of humans on the Moon or Mars, we must develop methods for on-site production of pharmaceutical peptides in space, a concept we call the Astropharmacy. Here, we present a proof-of-concept for the first step needed: a low-mass system for pharmaceutical production designed to be stable in space. To demonstrate feasibility, we engineered strains of the space-hardy spore-forming bacterium, Bacillus subtilis, to secrete two pharmaceutical peptides important for astronaut health: teriparatide (an anabolic agent for combating osteoporosis) and filgrastim (an effective countermeasure for radiation-induced neutropenia). We found that the secretion peptides from the walM and yoqH genes of B. subtilis worked well for secreting teriparatide and filgrastim, respectively. In consideration of the Translational Research Institute for Space Health (TRISH) challenge to produce a dose equivalent in 24 h, dried spores of our engineered strains were used to produce 1 dose equivalent of teriparatide from a 2 mL culture and 1 dose equivalent of filgrastim from 52 mL of culture in 24 h. Further optimization of strain growth conditions, expression conditions, and promoter sequences should allow for higher production rates to be achieved. These strains provide the template for future optimization efforts and address the first step in the Astropharmacy, capable of on-site production, purification, and processing of biopharmaceutical compounds in platforms amenable for use in space.

Alec Vallota-Eastman↗
NASA NTRS1984

Marketing the use of the space environment for the processing of biological and pharmaceutical materials

The perceptions of U.S. biotechnology and pharmaceutical companies concerning the potential use of the space environment for the processing of biological substances was examined. Physical phenomena that may be important in space-base processing of biological materials are identified and discussed in the context of past and current experiment programs. The capabilities of NASA to support future research and development, and to engage in cooperative risk sharing programs with industry are discussed. Meetings were held with several biotechnology and pharmaceutical companies to provide data for an analysis of the attitudes and perceptions of these industries toward the use of the space environment. Recommendations are made for actions that might be taken by NASA to facilitate the marketing of the use of the space environment, and in particular the Space Shuttle, to the biotechnology and pharmaceutical industries.

Source record↗
NASA NTRS1992

Large scale crystallization of protein pharmaceuticals in microgravity via temperature change

The major objective of this research effort is the temperature driven growth of protein crystals in large batches in the microgravity environment of space. Pharmaceutical houses are developing protein products for patient care, for example, human insulin, human growth hormone, interferons, and tissue plasminogen activator or TPA, the clot buster for heart attack victims. Except for insulin, these are very high value products; they are extremely potent in small quantities and have a great value per gram of material. It is feasible that microgravity crystallization can be a cost recoverable, economically sound final processing step in their manufacture. Large scale protein crystal growth in microgravity has significant advantages from the basic science and the applied science standpoints. Crystal growth can proceed unhindered due to lack of surface effects. Dynamic control is possible and relatively easy. The method has the potential to yield large quantities of pure crystalline product. Crystallization is a time honored procedure for purifying organic materials and microgravity crystallization could be the final step to remove trace impurities from high value protein pharmaceuticals. In addition, microgravity grown crystals could be the final formulation for those medicines that need to be administered in a timed release fashion. Long lasting insulin, insulin lente, is such a product. Also crystalline protein pharmaceuticals are more stable for long-term storage. Temperature, as the initiation step, has certain advantages. Again, dynamic control of the crystallization process is possible and easy. A temperature step is non-invasive and is the most subtle way to control protein solubility and therefore crystallization. Seeding is not necessary. Changes in protein and precipitant concentrations and pH are not necessary. Finally, this method represents a new way to crystallize proteins in space that takes advantage of the unique microgravity environment. The results from two flights showed that the hardware performed perfectly, many crystals were produced, and they were much larger than their ground grown controls. Morphometric analysis was done on over 4,000 crystals to establish crystal size, size distribution, and relative size. Space grown crystals were remarkably larger than their earth grown counterparts and crystal size was a function of PCF volume. That size distribution for the space grown crystals was a function of PCF volume may indicate that ultimate size was a function of temperature gradient. Since the insulin protein concentration was very low, 0.4 mg/ml, the size distribution could also be following the total amount of protein in each of the PCF's. X-ray analysis showed that the bigger space grown insulin crystals diffracted to higher resolution than their ground grown controls. When the data were normalized for size, they still indicated that the space crystals were better than the ground crystals.

Long, Marianna M.↗
NASA NTRS2007

Pharmaceutical Care and the Role of a Pharmacist in Space Medicine

Space medicine is primarily preventative medicine Outcomes of space medicine pharmaceutical care are: a) Elimination or reduction of a patient's symptomatology; b) Arresting or slowing of long term effects from microgravity; and c) Preventing long term effects or symptomatology as a result of microgravity. Space medicine pharmaceutical care is about both the patient and the mission. Pharmaceutical care in the area of space medicine is evolving. A pharmacist serves a critical role in this care. Commercial space travel will require pharmacist involvement.

Bayuse, Tina↗
NASA NTRS2009

Stability of Pharmaceuticals in Space

Stability testing is a tool used to access shelf life and effects of storage conditions for pharmaceutical formulations. Early research from the International Space Station (ISS) revealed that some medications may have degraded while in space. This potential loss of medication efficacy would be very dangerous to Crew health. The aim of this research project, Stability of Pharmacotherapeutic Compounds, is to study how the stability of pharmaceutical compounds is affected by environmental conditions in space. Four identical pharmaceutical payload kits containing medications in different dosage forms (liquid for injection, tablet, capsule, ointment and suppository) were transported to the ISS aboard a Space Shuttle. One of the four kits was stored on that Shuttle and the other three were stored on the ISS for return to Earth at various time intervals aboard a pre-designated Shuttle flight. The Pharmacotherapeutics laboratory used stability test as defined by the United States Pharmacopeia (USP), to access the degree of degradation to the Payload kit medications that may have occurred during space flight. Once these medications returned, the results of stability test performed on them were compared to those from the matching ground controls stored on Earth. Analyses of the results obtained from physical and chemical stability assessments on these payload medications will provide researchers additional tools to promote safe and efficacious medications for space exploration.

Nguyen, Y-Uyen↗
NASA NTRS2017

Radiation Impact on Pharmaceutical Stability: Retrospective Data Review

Historical studies performed by the JSC Pharmacotherapeutics Discipline suggest that exposure to spaceflight conditions may compromise the safety and efficacy of some medications. Follow-on studies have revealed that affected medications demonstrate reductions in active pharmaceutical ingredient (API) concentrations and altered release characteristics. It was hypothesized that the changes in API potency and release were from the medication's exposure to the harsh environmental conditions of spaceflight. Subsequent review of the spaceflight environmental control records from the time of these studies indicated that temperature and humidity levels aboard all spacecraft remained within United States Pharmacopeia (USP) recommended ranges to maintain optimal pharmaceutical stability. Therefore, space radiation was presumed to be the source of observed drug degradation. The Pharmacotherapeutics Discipline conducted a ground analog radiation experiment in 2006 at the NASA Space Radiation Laboratory (NSRL) at Brookhaven to validate this theory and to characterize the effects of high-energy radioactive particles on pharmaceutical stability. These data were never published. Recently, the Exploration Medical Capability (ExMC) Element finalized a research plan (RP) aimed at providing a safe and effective medication formulary for exploration spaceflight. As ExMC begins to design new flight and ground analog radiation studies, further analysis of the 2006 NSRL study data is essential for the characterization of the impact of radiation on medication potency and efficacy in the exploration spaceflight environment.

Daniels, V. R.↗
NASA NTRSDate not supplied

Preliminary Results Using Galvanic Vestibular Reduction as a Non-Pharmaceutical Tool for Motion Sickness Mitigation

Introduction: Alterations in vestibular sensory processing following G-transitions lead to motion sickness and spatial disorientation upon return to Earth’s gravity. The use of non-pharmaceutical mitigation for motion sickness has several potential advantages over drug treatment options. The purpose of this study was to validate a non-pharmaceutical tool using galvanic vestibular reduction (GVR) to mitigate G-transitional induced motion sickness and spatial disorientation. Methods: Using a repeated measures counter-balanced design, motion sickness and perception are obtained during Coriolis cross-coupling stimuli on a rotating chair across three GVR treatment interventions: throughout stimulus testing (prevention), following symptom onset (rescue), and placebo control. Subjects perform up to 10 sets of pitch head movements during constant rotation. For each set, head movement is cued every 10 seconds, alternating between pitch forward (chin resting to chest) and pitch backward (head upright) for a total of 7 forward and backward movements. During each head movement, subjects are asked to use a joystick to record the magnitude of their perceived rotation along all three axes. During the 2-minute pause between sets, motion sickness symptom scoring was obtained using the Pensacola Diagnostic Index and subject discomfort (0-20) ratings. Performance on a sensorimotor and cognitive test battery is measured during a fourth session to map changes in GVR level with functional performance. Results: Fifteen of 30 subjects have completed testing to date. Preliminary findings suggest GVR may be more effective in reducing symptoms in subjects who self-report less susceptibility on a pre-test motion sickness susceptibility questionnaire. Based on the joystick measures, GVR significantly reduces both the magnitude (mean 22% - 34%) and duration (mean 42% - 49%) of perceived roll and pitch sensation with head movements during constant rotation. It is important to note that comparable levels of GVR (up to 2.5mA) does not impair performance on a functional test battery including mobility and balance tasks. Discussion: Our preliminary findings suggest GVR may be useful in reducing disorienting roll and pitch illusions associated with Coriolis cross-coupling stimuli. While transfer to post-flight treatment will need to be validated, the potential advantages of our non-pharmaceutical countermeasure approach would be to provide rapid therapeutic effect while allowing continuous titration of GVR amplitude during recovery to maintain operational performance.

Gaurav Pradhan↗
NASA NTRS1978

Feasibility of commercial space manufacturing, production of pharmaceuticals. Volume 1: Executive summary

The feasibility of the commercial manufacturing of pharmaceuticals in space is examined. The method of obtaining pharmaceutical company involvement, laboratory results of the separation of serum proteins by the continuous flow electrophoresis process, the selection and study of candidate products, and their production requirements is presented. Antihemophilic factor, beta cells, erythropoietin, epidermal growth factor, alpha-1-antitrypsin and interferon were studied. Production mass balances for antihemophilic factor, beta cells, and erythropoietin were compared for space verus ground operation.

Source record↗
NASA NTRS1978

Feasibility of commercial space manufacturing, production of pharmaceuticals. Volume 2: Technical analysis

A technical analysis on the feasibility of commercial manufacturing of pharmaceuticals in space is presented. The method of obtaining pharmaceutical company involvement, laboratory results of the separation of serum proteins by the continuous flow electrophoresis process, the selection and study of candidate products, and their production requirements is described. The candidate products are antihemophilic factor, beta cells, erythropoietin, epidermal growth factor, alpha-1-antitrypsin and interferon. Production mass balances for antihemophelic factor, beta cells, and erythropoietin were compared for space versus ground operation. A conceptual description of a multiproduct processing system for space operation is discussed. Production requirements for epidermal growth factor of alpha-1-antitrypsin and interferon are presented.

Source record↗
NASA NTRSDate not supplied

A Qualitative Systematic Review Evaluating the Impact of Elevated Ambient Co2 in Atmosphere on Pharmaceutical Stability

Pharmaceuticals are an essential component of the medical system for crewed missions. Current research has identified decreased stability in space-flown pharmaceuticals compared to ground controls, and this presents a significant risk for future exploration-class missions where resupply will be limited. While the cause is not known, the elevated ambient carbon dioxide (CO2) in the spacecraft atmosphere has been postulated as a potential cause.

A Yuen↗
NASA NTRSDate not supplied

Decision Framework for Classifying the State of Knowledge for Pharmaceutical Stability in Spaceflight

The currently approved medication formulary for exploration-class spaceflight missions presently exceeds 200pharmaceuticals. However, these medications' physical and chemical stability during long-term exposure to the spaceflight environment remains uncharacterized. A multi-disciplinary team of pharmacy and spaceflight subject matter experts (SMEs) collaborated to develop a decision framework that will prioritize medications for future stability research. This framework prioritizes the physical stability, drug quality, and safety of the active pharmaceutical ingredient of finished drug products selected for specific design reference mission (DRM) drug formularies. The United States Pharmacopeia (USP) defines drug stability as "the extent to which a drug product retains, within specified limits, and throughout its period of storage and use, the same properties and characteristics that it possessed at the time of its manufacture.1"The candidate medication is assessed by applying a sequence of drug agnostic questions to evaluate the limits of stability information pertinent to spaceflight. The answers to these questions ultimately lead to one of three characterizations: green (not prioritized for further research for this DRM), yellow (requires further literature review/additional studies), or red (not suitable for this DRM based on current knowledge). The decision framework will rely on several information resources to inform the ultimate decision, including the ExMC Pharmacy Information Database, published literature, FDA/drug manufacturer monographs, and USP. The results of this framework will be used to classify the state of knowledge for pharmaceutical stability for any specified DRM and guide future research efforts accordingly. This presentation will provide an overview of how this decision framework was developed, detail the challenges and limitations of the pathways, and discuss how researchers can apply the lessons learned from this project to future work

S Kurian↗
NASA NTRSDate not supplied

Preliminary Results Using Galvanic Vestibular Reduction as a Non-Pharmaceutical Tool for Motion Sickness Mitigation

Alterations in vestibular sensory processing following G-transitions lead to motion sickness and spatial disorientation upon return to Earth’s gravity. The use of non-pharmaceutical mitigation for motion sickness has several potential advantages over drug treatment options. The purpose of this study was to validate a non-pharmaceutical tool using galvanic vestibular reduction (GVR) to mitigate G-transitional induced motion sickness and spatial disorientation.

G N Pradhan↗