CLINICAL TRIALS PROFILE FOR TPN ELECTROLYTES IN PLASTIC CONTAINER

505(b)(2) Clinical Trials for TPN ELECTROLYTES IN PLASTIC CONTAINER

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT02909036 ↗	Study of Captisol Enabled Melphalan and Pharmacokinetics for Patients With Multiple Myeloma or Light Chain Amyloidosis That Are Receiving an Autologous Transplant.	Active, not recruiting	Spectrum Pharmaceuticals, Inc	Phase 1	2016-09-01	Captisol Enabled Melphalan, is a new formulation of the standard of care melphalan chemotherapy that in packaged in an inactive substance that is believed to help the chemotherapy be more stable (meaning that it doesn't lose its effect or need to be administered quickly after being mixed). It may also have fewer side effects such as problems with important levels of body electrolytes such as potassium, phosphorous and magnesium; and cause less kidney and heart damage] than standard formulation melphalan. The purpose of this study is to determine if the investigators can achieve a certain level of Captisol Enabled Melphalan that would be best to use in treating Multiple Myeloma and AL Amyloidosis.
New Formulation	NCT02909036 ↗	Study of Captisol Enabled Melphalan and Pharmacokinetics for Patients With Multiple Myeloma or Light Chain Amyloidosis That Are Receiving an Autologous Transplant.	Active, not recruiting	Memorial Sloan Kettering Cancer Center	Phase 1	2016-09-01	Captisol Enabled Melphalan, is a new formulation of the standard of care melphalan chemotherapy that in packaged in an inactive substance that is believed to help the chemotherapy be more stable (meaning that it doesn't lose its effect or need to be administered quickly after being mixed). It may also have fewer side effects such as problems with important levels of body electrolytes such as potassium, phosphorous and magnesium; and cause less kidney and heart damage] than standard formulation melphalan. The purpose of this study is to determine if the investigators can achieve a certain level of Captisol Enabled Melphalan that would be best to use in treating Multiple Myeloma and AL Amyloidosis.
New Formulation	NCT00490932 ↗	New Hypo-Osmolar ORS (Recommended by WHO) for Routine Use in the Diarrhea Management- Surveillance Study for Adverse Effects	Completed	Society for Applied Studies	Phase 4	2005-03-01	For more than 25 years WHO and UNICEF have recommended a single formulation of glucose-based Oral Rehydration Salts (ORS) to prevent or treat dehydration from diarrhoea irrespective of the cause or age group affected. This product has proven effective and contributed substantially to the dramatic global reduction in mortality from diarrhoeal disease during the period. Based on more than two decades of research and recommendations by an expert group, WHO and UNICEF reviewed the effectiveness of a new ORS formula with reduced concentration of glucose and salts. Because of the improved effectiveness of this new ORS solution WHO and UNICEF recommended that countries use and manufacture this new formulation in place of the old one. While recommending this new ORS the experts also recommended that further monitoring is desirable to better assess the risk, if any of symptomatic hyponatraemia (low blood level of sodium salt). This is a surveillance study to evaluate adverse effect of routinely using the new ORS in a hospital admitting over 20,000 patients with diarrhea of all ages including cholera. If the new ORS is found safe, it will provide added confidence in its global use.
New Formulation	NCT00627796 ↗	Lanreotide Autogel-120 mg as First-Line Treatment of Acromegaly	Completed	University of Genova	Phase 4	2003-01-01	Recently, a new formulation of lanreotide, lanreotide Autogel (ATG) 60 mg, 90 mg and 120 mg was developed in order to further extend the duration of the release of the active ingredient. The ATG formulation consists of a solution of lanreotide in water with no additional excipients. ATG was found to have linear pharmacokinetics for the 60 to 120 mg doses and provided a prolonged dosing interval and good tolerability (1). In some previous studies, the ATG was demonstrated as effective as the micro-particle lanreotide (2,3) and as octreotide-LAR in patients with acromegaly (4-7). Data on the efficacy of ATG in newly diagnosed patients with acromegaly are still lacking. Similarly, the prevalence and amount of tumor shrinkage after ATG treatment is unknown. This information is particularly useful in the setting of first-line therapy of acromegaly that is currently becoming a more frequent approach to the disease (8). It is demonstrated that approximately 80% of the patients treated with depot somatostatin analogues as first line have a greater than 20% tumor shrinkage during the first 12 months of treatment (9). A definition of significant tumor shrinkage was provided in 14 studies (including a total number of patients of 424) and the results showed that 36.6% (weighted mean percentage) of patients receiving first-line somatostatin analogues therapy for acromegaly had a significant reduction in tumor size (10). About 50% of the patients were found to have a greater than 50% tumor shrinkage within the first year of treatment (10); in this study we found that percent decrease in IGF-I levels was the major determinant of tumor shrinkage (10). The current open, prospective study is designed to investigate the prevalence and amount of tumor shrinkage in newly diagnosed patients with acromegaly treated first-line with ATG.
New Formulation	NCT00627796 ↗	Lanreotide Autogel-120 mg as First-Line Treatment of Acromegaly	Completed	Federico II University	Phase 4	2003-01-01	Recently, a new formulation of lanreotide, lanreotide Autogel (ATG) 60 mg, 90 mg and 120 mg was developed in order to further extend the duration of the release of the active ingredient. The ATG formulation consists of a solution of lanreotide in water with no additional excipients. ATG was found to have linear pharmacokinetics for the 60 to 120 mg doses and provided a prolonged dosing interval and good tolerability (1). In some previous studies, the ATG was demonstrated as effective as the micro-particle lanreotide (2,3) and as octreotide-LAR in patients with acromegaly (4-7). Data on the efficacy of ATG in newly diagnosed patients with acromegaly are still lacking. Similarly, the prevalence and amount of tumor shrinkage after ATG treatment is unknown. This information is particularly useful in the setting of first-line therapy of acromegaly that is currently becoming a more frequent approach to the disease (8). It is demonstrated that approximately 80% of the patients treated with depot somatostatin analogues as first line have a greater than 20% tumor shrinkage during the first 12 months of treatment (9). A definition of significant tumor shrinkage was provided in 14 studies (including a total number of patients of 424) and the results showed that 36.6% (weighted mean percentage) of patients receiving first-line somatostatin analogues therapy for acromegaly had a significant reduction in tumor size (10). About 50% of the patients were found to have a greater than 50% tumor shrinkage within the first year of treatment (10); in this study we found that percent decrease in IGF-I levels was the major determinant of tumor shrinkage (10). The current open, prospective study is designed to investigate the prevalence and amount of tumor shrinkage in newly diagnosed patients with acromegaly treated first-line with ATG.
New Formulation	NCT00244777 ↗	Introduction of Hypo-osmolar ORS for Routine Use	Completed	United States Agency for International Development (USAID)	Phase 4	2002-12-01	The World Health Organization has very recently recommended the routine use of a hypo-osmolar ORS in the management of diarrhoeal diseases. This recommendation is based on the better efficacy of the hypo-osmolar ORS over the standard WHO ORS demonstrated in controlled clinical trials. The recommendation, however, also expressed the need for "careful monitoring to better assess risk, if any, of symptomatic hyponatraemia". There thus is a need for phase IV trials before the new solution is introduced into routine clinical practice to assess the risk in relatively large number of patient populations. The proposed study will be carried out at two different settings- at the urban settings of the Dhaka Hospital (60000 patients) and at the rural settings of the Matlab Hospital (15000 patients) of ICDDR,B. The hypo-osmolar rice or glucose-based ORS will be introduced as standard management of patients with diarrhoea . The hypo-osmolar ORS will contain 75 mmol /L of sodium instead of 90 mmol/L. Surveillance will be carried out to detect adverse events focusing on the occurrence of seizures or undue lethargy during hospitalization. Each episode of seizure or undue lethargy would be evaluated to determine if they are associated with abnormal levels of serum sodium or glucose, or fever. It has been estimated that about 3% (1,800) of patients initially admitted to the Short Stay Ward of the Dhaka Hospital, and 340 patients at the Matlab Hospital might require admission to the longer stay inpatient wards due to seizure or altered consciousness. Such patients would be thoroughly assessed including determination of their serum sodium and glucose, two common causes of seizures/altered consciousness, to determine if and to what extent they could be attributed to hyponatraemia.The results from this study would be used in planning and implementing the routine use of the new formulation of ORS at all Government, NGO and private health care facilities that treat diarrhoeal patients, in Bangladesh and in other countries.
New Formulation	NCT00244777 ↗	Introduction of Hypo-osmolar ORS for Routine Use	Completed	International Centre for Diarrhoeal Disease Research, Bangladesh	Phase 4	2002-12-01	The World Health Organization has very recently recommended the routine use of a hypo-osmolar ORS in the management of diarrhoeal diseases. This recommendation is based on the better efficacy of the hypo-osmolar ORS over the standard WHO ORS demonstrated in controlled clinical trials. The recommendation, however, also expressed the need for "careful monitoring to better assess risk, if any, of symptomatic hyponatraemia". There thus is a need for phase IV trials before the new solution is introduced into routine clinical practice to assess the risk in relatively large number of patient populations. The proposed study will be carried out at two different settings- at the urban settings of the Dhaka Hospital (60000 patients) and at the rural settings of the Matlab Hospital (15000 patients) of ICDDR,B. The hypo-osmolar rice or glucose-based ORS will be introduced as standard management of patients with diarrhoea . The hypo-osmolar ORS will contain 75 mmol /L of sodium instead of 90 mmol/L. Surveillance will be carried out to detect adverse events focusing on the occurrence of seizures or undue lethargy during hospitalization. Each episode of seizure or undue lethargy would be evaluated to determine if they are associated with abnormal levels of serum sodium or glucose, or fever. It has been estimated that about 3% (1,800) of patients initially admitted to the Short Stay Ward of the Dhaka Hospital, and 340 patients at the Matlab Hospital might require admission to the longer stay inpatient wards due to seizure or altered consciousness. Such patients would be thoroughly assessed including determination of their serum sodium and glucose, two common causes of seizures/altered consciousness, to determine if and to what extent they could be attributed to hyponatraemia.The results from this study would be used in planning and implementing the routine use of the new formulation of ORS at all Government, NGO and private health care facilities that treat diarrhoeal patients, in Bangladesh and in other countries.

All Clinical Trials for TPN ELECTROLYTES IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004360 ↗	Study of Genotype and Phenotype Expression in Congenital Nephrogenic Diabetes Insipidus	Completed	Northwestern University		1995-09-01	OBJECTIVES: I. Determine the relationship between genotype variations and clinical phenotype in patients with congenital nephrogenic diabetes insipidus.
NCT00004360 ↗	Study of Genotype and Phenotype Expression in Congenital Nephrogenic Diabetes Insipidus	Completed	National Center for Research Resources (NCRR)		1995-09-01	OBJECTIVES: I. Determine the relationship between genotype variations and clinical phenotype in patients with congenital nephrogenic diabetes insipidus.
NCT00004328 ↗	Phase II Study of the Pathophysiology and Treatment With Enalapril and Polystyrene Sulfonate for Pseudohypoaldosteronism, Type I	Completed	University of Texas	Phase 2	1992-12-01	OBJECTIVES: I. Establish the sodium and potassium intake that will maintain a normovolemic state in a patient with pseudohypoaldosteronism. II. Determine the effect of extracellular fluid volume and serum potassium manipulations on exercise tolerance, cardiac function, and endurance. III. Investigate pharmacologic methods of limiting excretion of sodium in urine and sweat.
NCT00004328 ↗	Phase II Study of the Pathophysiology and Treatment With Enalapril and Polystyrene Sulfonate for Pseudohypoaldosteronism, Type I	Completed	National Center for Research Resources (NCRR)	Phase 2	1992-12-01	OBJECTIVES: I. Establish the sodium and potassium intake that will maintain a normovolemic state in a patient with pseudohypoaldosteronism. II. Determine the effect of extracellular fluid volume and serum potassium manipulations on exercise tolerance, cardiac function, and endurance. III. Investigate pharmacologic methods of limiting excretion of sodium in urine and sweat.
NCT00000574 ↗	Ibuprofen in Sepsis Study	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1990-09-01	To determine the effects of ibuprofen on mortality, development and reversal of shock, and adult respiratory distress syndrome, and on Lung Parenchymal Injury Score in adult patients with serious infection.
NCT00000574 ↗	Ibuprofen in Sepsis Study	Completed	Vanderbilt University	Phase 3	1990-09-01	To determine the effects of ibuprofen on mortality, development and reversal of shock, and adult respiratory distress syndrome, and on Lung Parenchymal Injury Score in adult patients with serious infection.
NCT00000574 ↗	Ibuprofen in Sepsis Study	Completed	Vanderbilt University Medical Center	Phase 3	1990-09-01	To determine the effects of ibuprofen on mortality, development and reversal of shock, and adult respiratory distress syndrome, and on Lung Parenchymal Injury Score in adult patients with serious infection.

Clinical Trial Conditions for TPN ELECTROLYTES IN PLASTIC CONTAINER

Condition Name

Condition Name for TPN ELECTROLYTES IN PLASTIC CONTAINER
Intervention	Trials
Schizophrenia	11
Heart Failure	9
Hypertension	9
Healthy	8

Condition MeSH

Condition MeSH for TPN ELECTROLYTES IN PLASTIC CONTAINER
Intervention	Trials
Syndrome	22
Heart Failure	20
Hypertension	15
Kidney Diseases	14

Clinical Trial Locations for TPN ELECTROLYTES IN PLASTIC CONTAINER

Trials by Country

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−

Trials by Country for TPN ELECTROLYTES IN PLASTIC CONTAINER
Location	Trials
United States	344
Canada	37
China	35
United Kingdom	34
Egypt	25

Trials by US State

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−

Trials by US State for TPN ELECTROLYTES IN PLASTIC CONTAINER
Location	Trials
Texas	39
New York	32
California	27
Maryland	22
Pennsylvania	20

Clinical Trial Progress for TPN ELECTROLYTES IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for TPN ELECTROLYTES IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Phase 4	114
Phase 3	59
Phase 2/Phase 3	17

Clinical Trial Status

Clinical Trial Status for TPN ELECTROLYTES IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	211
Recruiting	55
Terminated	46

Clinical Trial Sponsors for TPN ELECTROLYTES IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for TPN ELECTROLYTES IN PLASTIC CONTAINER
Sponsor	Trials
Baylor College of Medicine	8
University of North Carolina, Chapel Hill	8
University of Maryland	8

Sponsor Type

Sponsor Type for TPN ELECTROLYTES IN PLASTIC CONTAINER
Sponsor	Trials
Other	659
Industry	115
NIH	31

TPN Electrolytes in Plastic Containers: Clinical, Market, and Projection Analysis

Introduction

Total Parenteral Nutrition (TPN) Electrolytes are crucial for maintaining normal cellular metabolism in patients receiving total parenteral nutrition. This article will delve into the clinical aspects, market analysis, and future projections of TPN Electrolytes, particularly those packaged in plastic containers.

Clinical Overview of TPN Electrolytes

Composition and Function

TPN Electrolytes are a sterile, nonpyrogenic, concentrated solution containing sodium chloride, calcium chloride, potassium chloride, magnesium chloride, and sodium acetate anhydrous. These electrolytes are essential for preventing deficiency symptoms and maintaining cellular metabolism during TPN therapy[2][4].

Administration and Dosage

TPN Electrolytes are added to amino acid/dextrose solutions, typically at a rate of 20 mL per liter. The solution must be diluted and thoroughly mixed before intravenous administration through a central venous catheter. The daily administration usually ranges between two to three liters, given continuously over 24 hours at a constant rate of 83 to 125 mL/hour[2][4].

Precautions and Contraindications

These electrolytes are contraindicated in conditions such as anuria, hyperkalemia, heart block, myocardial damage, and severe edema due to cardiovascular, renal, or hepatic failure. Patients should be monitored for signs of overhydration or solute overload, and the solution should be inspected visually for particulate matter and discoloration before administration[2][4].

Clinical Trials and Safety Data

Current Clinical Experience

There are no specific clinical trials dedicated solely to TPN Electrolytes, as they are part of the broader TPN regimen. However, the safety and efficacy of TPN Electrolytes have been established through their widespread use in clinical practice. The literature indicates no significant differences in response between elderly and younger patients, although dose selection for elderly patients should be cautious due to potential decreased hepatic, renal, or cardiac function[1][2].

Reproductive and Pediatric Considerations

Animal reproduction studies have not been conducted with TPN Electrolytes, and it is not known whether they can cause fetal harm or affect reproduction capacity. Therefore, they should be used in pregnant women only if clearly needed[1].

Market Analysis

Current Market Trends

The market for TPN solutions, including electrolyte additives, is driven by the increasing demand for parenteral nutrition due to rising cases of malnutrition, gastrointestinal disorders, and other conditions requiring intravenous nutrition. The use of plastic containers, particularly polypropylene vials, is gaining traction due to their convenience, higher melting points, and suitability for autoclaving[5].

Competitive Landscape

The market for TPN Electrolytes is competitive, with several pharmaceutical companies such as Hospira, Inc. providing these solutions. The competition is based on factors such as product formulation, packaging, and distribution efficiency. Polypropylene vials are emerging as a preferred option due to their flexibility and operational advantages[5].

Future Projections

Technological Advancements

The shift towards polypropylene vials is expected to continue, driven by their advantages in terms of filling speeds, transportation, and storage. This could lead to increased market share for companies adopting these newer packaging technologies[5].

Regulatory Environment

Regulatory bodies are likely to continue emphasizing the importance of quality-by-design development and adequate control strategies to ensure the safety and efficacy of TPN Electrolytes. Compliance with USP biological standards for plastic containers will remain a critical factor[1][2].

Market Growth

The demand for TPN solutions, including electrolyte additives, is projected to grow due to an increasing global population with nutritional deficiencies and the expanding use of parenteral nutrition in various clinical settings. The market is expected to see steady growth, driven by advancements in packaging technology and the increasing need for efficient and safe nutritional solutions[5].

Key Takeaways

• Clinical Importance: TPN Electrolytes are crucial for maintaining cellular metabolism in patients receiving total parenteral nutrition.
• Administration: These electrolytes must be diluted and mixed thoroughly before intravenous administration.
• Precautions: Contraindicated in certain pathological conditions and require careful monitoring.
• Market Trends: The market is shifting towards polypropylene vials due to their operational advantages.
• Future Projections: Expected growth driven by technological advancements and increasing demand for parenteral nutrition.

FAQs

What are the main components of TPN Electrolytes?

TPN Electrolytes contain sodium chloride, calcium chloride, potassium chloride, magnesium chloride, and sodium acetate anhydrous[2][4].

How are TPN Electrolytes administered?

TPN Electrolytes are added to amino acid/dextrose solutions and administered intravenously through a central venous catheter at a rate of 20 mL per liter[2][4].

What are the contraindications for TPN Electrolytes?

Contraindications include conditions such as anuria, hyperkalemia, heart block, myocardial damage, and severe edema due to cardiovascular, renal, or hepatic failure[2][4].

Why are polypropylene vials gaining popularity for TPN solutions?

Polypropylene vials offer advantages such as higher melting points, suitability for autoclaving, and improved transportation and storage efficiency[5].

What is the expected market growth for TPN Electrolytes?

The market is expected to see steady growth driven by advancements in packaging technology and the increasing need for efficient and safe nutritional solutions[5].

Sources

1. Pfizer Labeling: TPN Electrolytes (multiple electrolyte additive) - Clinical Pharmacology.
2. DailyMed: TPN Electrolytes - Sodium Chloride, Calcium Chloride, Potassium Chloride, Magnesium Chloride, and Sodium Acetate Anhydrous Injection, Solution, Concentrate.
3. ClinicalTrials.gov: TACL - ClinicalTrials.gov (not directly relevant but provides context on clinical trials).
4. DailyMed: TPN ELECTROLYTES - Sodium Chloride, Calcium Chloride, Potassium Chloride, Magnesium Chloride, and Sodium Acetate Anhydrous Injection, Solution, Concentrate.
5. PDA: Time to Start Using Polypropylene Vials in the Industry.