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API Sal Selec ion: A Classical bu E ol ing App oach in Mode n D ug De elopmen
Ti upa hi Mannala *
Depa men o Pha maceu ics, S . Pe e 's Ins i u e o Pha maceu ical Sciences, Hanamkonda, Telangana 506001.
GSC Biological and Pha maceu ical Sciences, 2025, 33(01), 066-072
Publica ion his o y: Recei ed on 31 Augus 2025; e ised on 06 Oc obe 2025; accep ed on 08 Oc obe 2025
A icle DOI: h ps://doi.o g/10.30574/gscbps.2025.33.1.0382
Abs ac
Fo se e al decades, gene a ing sal o ms o he ac i e pha maceu ical ing edien s (APIs) has emained he p e e ed
app oach o he pha maceu ical indus ies. The sal o m o he APIs p o ides he ad an age o imp o ing he solubili y
and s abili y, enhancing he dissolu ion a e, pe meabili y, manu ac u ing obus ness, as e masking, and li e cycle
managemen . The pha maceu ical sal s a e he ionic compounds o a d ug and i s coun e ion. The coun e ions can be
classi ied as anionic, ca ionic, o ganic anions, and a oma ic sul ona es. The sal o m o he d ug does no exhibi pH-
dependen solubili y. De eloping a sal o m o he d ug will imp o e he bioa ailabili y o poo ly soluble d ugs
belonging o he biopha maceu ical classi ica ion sys em (BCS) class II and IV. A ound 50% o he solid o al dosage
o ms in he ma ke u ilize he sal o m o he d ug. Iden i ying he sui able sal o m igh in he ea ly s ages o
de elopmen will elimina e he need o complex o mula ion pla o ms such as amo phous solid dispe sions. Despi e
a ious ad an ages, a ew limi a ions mus be add essed, such as hyg oscopici y, polymo phism, and coun e ions. The
sal sc eening can be in eg a ed wi h a i icial in elligence (AI) and compu a ional ools o accele a e de elopmen . The
e iew a icle summa izes he p inciples, bene i s, limi a ions, and u u e ou look o pha maceu ical sal s.
Keywo ds: Sal Fo m; Solubili y Enhancemen ; Bioa ailabili y; A i icial In elligence; Coun e ion; Hyg oscopici y
1. In oduc ion
Poo solubili y is he cen al issue aced by he pha maceu ical indus y, equi ing explo a ion o ad anced o mula ion
pla o ms. De eloping pha maceu ical sal s is he mos common s a egy implemen ed by he pha maceu ical indus y.
The pha maceu ical sal s a e ionic compounds o med by a eac ion be ween acidic and basic d ug subs ances and
sui able coun e ions [1–3]. The objec i e o de eloping pha maceu ical sal s is o imp o e he physical and chemical
cha ac e is ics wi hou comp omising he pha macological ac ion. A ound 50% o he d ug p oduc s wi hin he ma ke
consis o he sal o m o he d ug. The pha maceu ical sal s we e in oduced in o he ma ke om he ime o Aspi in.
De eloping pha maceu ical sal s will esul in imp o ed solubili y o biopha maceu ical classi ica ion sys em (BCS)
class II (Poo Solubili y, High Pe meabili y) and IV (Poo Solubili y, Poo Pe meabili y) d ugs [4–8]. E alua ing he
easibili y o sal o m o imp o ing he solubili y du ing he ea ly disco e y phase o he de elopmen would sa e a
lo o ime o he pha maceu ical indus y. Iden i ying a s able sal o m is c ucial o p e en ing se ious p oblems in
he u u e. In ac , de eloping sal o m can be in eg a ed wi hin he ac i e pha maceu ical ing edien (API)
manu ac u ing p ocess, elimina ing he need o ad anced o mula ion s a egies [9–13].
O he solubili y-enhancing app oaches include coc ys als, co-amo phous sys ems, complexa ion, mic oniza ion, lipid-
based o mula ions, and amo phous solid dispe sions [14, 15]. Wi hin he d ug de elopmen p ocess, e alua ing sal
o m sc eening will be he i s line s a egy be o e assessing he easibili y o o he app oaches. Thus, pha maceu ical
sal s a e essen ial wi hin he indus y and align wi h egula o y equi emen s [16–18]. Implemen ing sal o ms also
p o ides an oppo uni y o li e cycle managemen and pa en abili y in he indus y. Once a sui able coun e ion is
GSC Biological and Pha maceu ical Sciences, 2025, 33(01), 066-072
67
iden i ied, conduc ing polymo ph sc eening is essen ial o de eloping a s able sal o m. The e iew a icle summa izes
he p inciples, bene i s, limi a ions, and u u e ou look o pha maceu ical sal s.
2. Ra ionale o sal o ma ion
Any o al medica ion should dissol e in he gas ic en i onmen and pe mea e h ough he biological memb ane in o
he sys emic ci cula ion o each he a ge si e o ac ion. Solubili y and pe meabili y a e c ucial o he d ug o be
bioa ailable. De eloping a sal o m o he d ug will imp o e he solubili y and enhance he dissolu ion a e and
pe meabili y. The sal o m o he d ug will in luence he lipophilici y, he eby p omo ing d ug pe mea ion [19–21].
Since mos o he d ug subs ances a e ei he acidic o basic, he sal o m o he d ug will exhibi pH-independen
solubili y, elimina ing he ole o physiological pH in he solubili y and pe o mance o he d ug. The sal o m o he
d ug will also imp o e he s abili y by p e en ing hyd olysis, oxida ion, and p o ec ing he d ug molecule om ligh .
The sal o m o he d ug will also al e he mel ing poin o he d ug, he eby enhancing i s s abili y [22–26]. The low
and comp essibili y o he sal o m will be supe io o ha o he nea d ug subs ance, acili a ing imp o ed p ocessing
o de eloping solid o al dosage o ms. The sal o m o he d ug will mask he as e o bi e APIs, imp o ing pala abili y
o he pa ien popula ion.
3. C i e ia o sal selec ion
Fo de eloping a obus and s able sal o m o he d ug, he di e ence in he pKa o he d ug and coun e ion should be
a leas 2-3 uni s. The sal o m should exhibi sa is ac o y solubili y ac oss he pH ange and emain s able a egula
and accele a ed s o age condi ions. The hyg oscopici y o he sal o m needs o be s udied o a oid s abili y challenges
[27–30]. I is ad isable o selec he coun e ion om he lis app o ed by he Food and D ug Adminis a ion (FDA),
which is non- oxic and sa e o human adminis a ion. The in i o pe o mance o he sal o m o he d ug needs o be
e alua ed using an animal model o compu a ional ools. The coun e ions ha migh cause gas ic i i a ion need o be
a oided. The compa ibili y o he sal o m wi h o he pha maceu ical excipien s needs o be s udied. The low
p ope ies and comp essibili y mus be assessed o ease d ug p oduc manu ac u ing. The egula o y his o y
conce ning he coun e ion needs o be examined be o ehand o a oid any las -minu e su p ises [31, 32]. The ease o
manu ac u ing he sal o m API mus also be e i ied and simpli ied i needed.
4. Commonly used sal - o ming agen s
Di e en ypes o coun e ions a e a ailable, which can be sc eened and selec ed based on he API's na u e and he sal
o m's objec i e. Fo acidic APIs, usually ca ionic-based coun e ions a e sui able o he o mula ion o sal o m,
whe eas anionic coun e ions a e needed o he basic d ugs. O he ypes o coun e ions include o ganic and a oma ic
sul ona es. Each ype o sal migh p o ide di e en bene i s. The sal o m o amlodipine besyla e has esul ed in
imp o ed solubili y, whe eas he sal o m o se aline hyd ochlo ide has aided bioa ailabili y enhancemen . The
calcium sal o m o a o as a in has imp o ed s abili y o he d ug subs ance. A ew o he coun e ions will p o ide a
dual e ec [33–37]. Fo example, ci a e coun e ion can aid bo h solubili y and bu e ing. Hyd ochlo ide sal o ms a e
sui able o basic d ugs. Coun e ions such as pe chlo a es need o be a oided due o oxici y conce ns. A de ailed lis o
commonly used coun e ions o de eloping pha maceu ical sal s is lis ed in Table 1.
Table 1 Lis o he mos used coun e ions o he de elopmen o pha maceu ical sal s.
Coun e ion Ca ego y
Examples
Ca ions
Sodium, po assium, calcium, magnesium
Anions
Hyd ochlo ide, sul a e, phospha e, ni a e
O ganic anions
Fuma a e, malea e, ci a e, a a e
A oma ic sul ona es
Besyla e, mesyla e, osyla e
5. Ad an ages and success s o ies
De eloping a sal o m o he d ug p o ides a ious ad an ages. Along wi h solubili y enhancemen , he sal o m o he
d ug will also imp o e bioa ailabili y and s abili y. The manu ac u abili y o he d ug p oduc using sal o m is supe io
o ha o he nea APIs. The sal o m o he d ugs will ha e be e low and comp essibili y. The a e o dissolu ion can
GSC Biological and Pha maceu ical Sciences, 2025, 33(01), 066-072
68
be imp o ed wi h he sal o m, which he eby p o ides a apid onse o ac ion o sho -ac ing d ugs and o d ugs wi h
sho e hal -li e. Inclusion o a ew coun e ions will educe he hyg oscopici y o he d ug, he eby enhancing s abili y
[38–42]. The sal o ms o he d ug also p o ide he lexibili y o de eloping injec ables. The injec able dosage o m
p e e s he sal o m o he d ug o p epa ing high-concen a ion d ug solu ions, he eby educing he dosing olume.
The sal o m o he d ug can mask he bi e as e o APIs, he eby imp o ing he pala abili y o he pedia ic pa ien
popula ion. The sal s can be e con ol he polymo phic o ms, esul ing in a obus , s able, and sa e API. De eloping a
sal o m o he d ug will allow li e cycle managemen o ex end he pa ien exclusi i y [43–46]. The a ious ad an ages
o e ed by pha maceu ical sal s a e shown in Figu e 1.
Figu e 1 Va ious ad an ages o e ed by pha maceu ical sal s
6. Limi a ions and challenges
A ew sal o ms will limi he solubili y o he d ugs, making hem sui able o con olled- elease dosage o ms bu no
o immedia e- elease medica ions. The pKa ule will no p oduce a s able sal o m in all si ua ions. A ew sal o ms
migh be hyg oscopic and equi e addi ional con ol measu es o p ese e s abili y [47–49]. A ew coun e ions migh
aid in solubili y enhancemen , bu need o be a oided due o oxic conce ns. The isk o polymo phism exis s o he sal
o m o he d ug and equi es a ho ough sc eening be o e a s able o m is iden i ied. The sal o m migh no add ess
he pe meabili y challenge in all si ua ions, especially o BCS class IV d ugs [50–54].
7. Fu u e pe spec i es
To accele a e he sc eening o sui able coun e ions o gene a ing s able sal o ms, compu a ional ools wi h a i icial
in elligence (AI) mus be in eg a ed [55, 56]. Mo e coun e ions ha a e sa e o human adminis a ion need o be
sc eened. The manu ac u ing p ocess needs o be op imized o educe he use o sol en s and p omo e g een chemis y
[57–61]. The easibili y o he sal o m o he d ug o de eloping o ally disin eg a ing able s needs o be e alua ed.
The sal o m o he d ugs can be used wi hin addi i e manu ac u ing echniques o c ea e pa ien -cen ic medica ions
[62].
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8. Conclusion
Sal o ms o he APIs a e he mos p e e ed app oach by he pha maceu ical indus y o imp o ing he solubili y and
s abili y o he medica ions. In si ua ions whe e de eloping a sal o m o he d ug is no easible, al e na e solubili y
enhancemen echniques will be e alua ed. Along wi h he ad an age o solubili y and s abili y enhancemen , he sal
o m also p o ides he oppo uni y o li e cycle managemen . A ew limi a ions, such as he oxici y o he coun e ions,
hyg oscopici y, and polymo phism, exis bu can be add essed by implemen ing ho ough sc eening echniques. The
u u e lies in he compu a ional ools, no el coun e ions, and in eg a ion wi h he ad anced d ug deli e y. Howe e , he
sal o m o he APIs will domina e he de elopmen o solid o al dosage o ms while nex -gene a ion app oaches a e
de eloped and implemen ed.
Compliance wi h e hical s anda ds
Disclosu e o con lic o in e es
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All aspec s o his wo k, including li e a u e e iew, analysis, and manusc ip p epa a ion, we e solely conduc ed by he
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The e iew a icle has ecei ed no ex e nal unding.
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