Evidence map›Paper›PMID 40660448›Full record

ReviewProtein and peptide letters2025

Protein and Peptide Therapeutics: Stability Challenges, Regulatory Demands, and Innovative Formulation Solutions for Enhanced Clinical Effectiveness.

Megha Patel, Dhruv Parikh, Akshay Parihar, Bhupendra Prajapati, Meenakshi B Patel, Sagar Salave, Ravi Patel, Rishabha Malviya, Rahul Maheshwari, Dignesh Khunt

Abstract readReview
PubMed Publisher
In one paragraph

Review in Protein and peptide letters, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Megha PatelGujarat Technological University, School of Pharmacy, Gandhinagar 382028, Gujarat, India.
Dhruv ParikhDepartment of Pharmaceutical Sciences, Saurashtra University, Rajkot-360005, India.
Akshay PariharFaculty of Pharmaceutical Sciences, The ICFAI University, Baddi, Himachal Pradesh, India.
Bhupendra PrajapatiS. K. Patel College of Pharmaceutical Education and Research, Ganpat University, Kherva, India.
Meenakshi B PatelDepartment of Pharmaceutics, Parul Institute of Pharmacy, Faculty of Pharmacy, Parul University, Waghodia, Vadodara - 391760, Gujarat, India.
Sagar SalaveNational Institute of Pharmaceutical Education and Research (NIPER), Ahmedabad 382355, India.
Ravi PatelGujarat Technological University, School of Pharmacy, Gandhinagar 382028, Gujarat, India.
Rishabha MalviyaDepartment of Pharmacy, School of Medical and Allied Sciences, Galgotias University, Noida, Uttar Pradesh; India.
Rahul MaheshwariSchool of Pharmacy and Technology Management, SVKM's NMIMS Deemed to be University, Jadcherla, Hyderabad-509301, India.
Dignesh KhuntGujarat Technological University, School of Pharmacy, Gandhinagar 382028, Gujarat, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Proteins and peptides play a crucial role in biological functions and contemporary therapeutic approaches; however, their clinical effectiveness is frequently hindered by swift renal clearance and enzymatic degradation. Peptides possess structured amino acid sequences that facilitate targeted drug delivery and enhance patient adherence. In contrast, proteins demonstrate intricate stability behaviors affected by pH and environmental conditions, requiring careful formulation strategies. Addressing these challenges necessitates a comprehensive understanding of stability and regulatory requirements. Regulatory agencies, including the FDA, EMA, and PMDA, require comprehensive stability testing per guidelines such as ICH Q5C and ICH Q1A(R2). This ensures meticulous management of factors such as temperature control, formulation optimization, and aggregation mitigation. Stability enhancement requires the application of innovative techniques, including protein engineering, lyoprotection, and nanoparticle encapsulation, in conjunction with ongoing quality monitoring. Integrating scientific expertise with regulatory standards enables researchers and pharmaceutical manufacturers to develop safe, effective, and compliant protein and peptide therapeutics for various patient populations.

Indexed as

PeptidesProteinsChemistry, PharmaceuticalDrug CompoundingDrug StabilityHumansProtein StabilityPeptidesProteinsbiological functionsenzymatic degradationnanoparticle encapsulationprotein engineeringprotein engineering.Proteins and peptidesstability testing

Identifiers

PMID40660448

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.