Evidence map›Paper›PMID 36678819›Full record

ReviewPharmaceutics2023

Co-Crystallization Approach to Enhance the Stability of Moisture-Sensitive Drugs.

Madhukiran R Dhondale, Pradip Thakor, Amritha G Nambiar, Maan Singh, Ashish K Agrawal, Nalini R Shastri, Dinesh Kumar

Open access · goldAbstract readReview
In one paragraph

Review in Pharmaceutics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
9.2field-weighted citation impact, top 1% of its field
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

14 citing papers in PubMed, 62 citations in OpenAlex.

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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

7 authors at 2 institutions in 1 country.

Madhukiran R DhondaleDepartment of Pharmaceutical Engineering and Technology, Indian Institute of Technology (BHU), Varanasi 221005, India.
Pradip ThakorNatco Research Center, Natco Pharma Limited, Hyderabad 500018, India.
Amritha G NambiarDepartment of Pharmaceutical Engineering and Technology, Indian Institute of Technology (BHU), Varanasi 221005, India.ORCID 0000-0003-4297-907X
Maan SinghDepartment of Pharmaceutical Engineering and Technology, Indian Institute of Technology (BHU), Varanasi 221005, India.ORCID 0000-0002-4622-3686
Ashish K AgrawalDepartment of Pharmaceutical Engineering and Technology, Indian Institute of Technology (BHU), Varanasi 221005, India.ORCID 0000-0002-7302-3647
Nalini R ShastriSolid State Pharmaceutical Research, Hyderabad 500037, India.
Dinesh KumarDepartment of Pharmaceutical Engineering and Technology, Indian Institute of Technology (BHU), Varanasi 221005, India.ORCID 0000-0001-9785-0500
Indian Institute of Technology BHU · INNatco Pharma (India) · IN

Funding

PMRF, India 1102018SERB, India SRG/2021/002389
6 · The paper itself

Abstract

Stability is an essential quality attribute of any pharmaceutical formulation. Poor stability can change the color and physical appearance of a drug, directly impacting the patient's perception. Unstable drug products may also face loss of active pharmaceutical ingredients (APIs) and degradation, making the medicine ineffective and toxic. Moisture content is known to be the leading cause of the degradation of nearly 50% of medicinal products, leading to impurities in solid dose formulations. The polarity of the atoms in an API and the surface chemistry of API particles majorly influence the affinity towards water molecules. Moisture induces chemical reactions, including free water that has also been identified as an important factor in determining drug product stability. Among the various approaches, crystal engineering and specifically co-crystals, have a proven ability to increase the stability of moisture-sensitive APIs. Other approaches, such as changing the salt form, can lead to solubility issues, thus making the co-crystal approach more suited to enhancing hygroscopic stability. There are many reported studies where co-crystals have exhibited reduced hygroscopicity compared to pure API, thereby improving the product's stability. In this review, the authors focus on recent updates and trends in these studies related to improving the hygroscopic stability of compounds, discuss the reasons behind the enhanced stability, and briefly discuss the screening of co-formers for moisture-sensitive drugs.

Indexed as

co-crystalshygroscopicitymoisture-sensitivestability

Identifiers

PMID36678819
PMCPMC9864382
OpenAlexW4313572550

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.