For­mu­la­ti­on Development

For­mu­la­ti­on Development

We are experts for for­mu­la­ti­on deve­lo­p­ment. Not only in theo­ry but also in prac­ti­ce. We love to assist you on spe­ci­fic issu­es in for­mu­la­ti­on deve­lo­p­ment. We can also sup­port you by con­duc­ting par­ti­cu­lar tri­als or even by taking care of the ent­i­re for­mu­la­ti­on deve­lo­p­ment. Our lab pro­vi­des the equip­ment requi­red for all rele­vant tri­als. We can get star­ted prompt­ly as we aren‘t bound to any GMP regu­la­ti­ons in our lab. This allows us to quick­ly obtain con­clu­si­ve results.

Small Sca­le Development

We deve­lo­ped a method that allows us to obtain reli­able results even with a very litt­le amount of API. We call this method „Small Sca­le Deve­lo­p­ment“. Using this method, we can save up to 95 % of API com­pa­red to con­ven­tio­nal ear­ly-sta­ge pro­ce­du­res and still make valid pre­dic­tions about tableta­bi­li­ty and future pro­du­ci­bi­li­ty. We‘d love to exp­lain this method to you in a per­so­nal con­ver­sa­ti­on. Just give us a call at +49(0)214 500 42 88 3.

The „Small Sca­le Deve­lo­p­ment“ method enab­les us to per­form many tri­als rele­vant for the for­mu­la­ti­on at a very ear­ly sta­ge of drug deve­lo­p­ment — exact­ly during the pha­se when the API is still very cos­t­ly and pro­du­ced only in limi­ted quan­ti­ties. The pos­si­bi­li­ty to deter­mi­ne the basics of for­mu­la­ti­on and pro­duc­tion method even pri­or to cli­ni­cal tri­als can redu­ce the time for mar­ket access considerably.

We deve­lop for­mu­la­ti­ons for direct table­ting, dry gra­nu­la­ti­on, flu­id bed and high she­ar gra­nu­la­ti­on. We can app­ly our „Small Sca­le Deve­lo­p­ment“ to all the­se pro­ce­du­res. Natu­ral­ly, we also sup­port you during tran­si­ti­ons in manu­fac­tu­ring pro­ces­ses or with other chal­len­ges con­nec­ted to for­mu­la­ti­on deve­lo­p­ment, for examp­le if you alrea­dy have a for­mu­la­ti­on and wish to opti­mi­ze it.

Once the for­mu­la­ti­on is estab­lis­hed, we do not lea­ve you high and dry: We also per­form sca­le-ups, defi­ne manu­fac­tu­ring inst­ruc­tions inclu­ding in-pro­cess con­trols, and super­vi­se the trans­fer to pro­duc­tion sites.

 

Pro­ce­du­re

First of all, we want to ful­ly under­stand your situa­ti­on and the pre­cise chal­len­ges. On this basis, we will work out a pro­po­sal for solu­ti­on. This pro­po­sal great­ly depends on the type of pro­blem and will be tailo­red indi­vi­du­al­ly for you. Below, you can see our basic model for for­mu­la­ti­on development:

As a rule, we start by cha­rac­te­ri­zing the pure API. Based on the­se results and your ide­as for pro­duc­tion set­ting and exci­pi­ents we will crea­te first sug­ges­ti­ons for the for­mu­la­ti­on. Depen­ding on the desi­red quan­ti­ty of acti­ve ingre­dient and the API‘s cha­rac­te­ris­tics we will be able to alrea­dy nar­row down the manu­fac­tu­ring methods. This is important as the manu­fac­tu­ring method influ­en­ces the choice of exci­pi­ents and exci­pi­ent qua­li­ties. In case you alrea­dy deter­mi­ned or favor a manu­fac­tu­ring method we can go accord­ing to your choice, of cour­se. We sup­port you with the deve­lo­p­ment of for­mu­la­ti­ons for direct table­ting, dry or, wet granulation.

 

The actu­al for­mu­la­ti­on deve­lo­p­ment (2nd step in dia­gram) is an ite­ra­ti­ve and agi­le pro­cess. Once the first for­mu­la­ti­ons are tes­ted we will ana­ly­ze the results and adjust the for­mu­la­ti­on accord­in­gly. We pre­fer kee­ping in clo­se con­ta­ct with you during the­se ite­ra­ti­ve steps. Howe­ver, you can also give us free rein and will recei­ve a reli­able for­mu­la­ti­on in the end. Natu­ral­ly, we also keep an eye on flowa­bi­li­ty, howe­ver, this can only be tes­ted ulti­mate­ly with lar­ger pro­duct quan­ti­ties  and on a rota­ry tablet press (3rd step in dia­gram). As a gene­ral rule, we always deve­lop for­mu­la­ti­ons with an eye towards future pro­duc­tion. Alrea­dy at this point, we pay atten­ti­on to the basics for a poten­ti­al sca­le-up and fea­si­ble pro­duc­tion pro­ces­ses. At this sta­ge, the focus is on the for­mu­la­ti­on its­elf and we pre­fer not to app­ly any pre-com­pac­tion for­ces. Pre-com­pac­tion for­ce and slight reduc­tions of table­ting speed should be reser­ved as resour­ce of ver­nier adjus­t­ment for the pro­duc­tion pro­cess when the for­mu­la­ti­on is established.

The next step of a com­pre­hen­si­ve for­mu­la­ti­on deve­lo­p­ment is to test the most pro­mi­sing can­di­da­tes from step 2 on a rota­ry tablet press in order to deter­mi­ne the flowa­bi­li­ty by refe­rence to the stan­dard devia­ti­on of weight. If necessa­ry, this step can also be post­po­ned to a time when the sup­ply of API is not as short any­mo­re. We can per­form the­se tri­als eit­her on a small rota­ry press in our lab, or on your actu­al pro­duc­tion press or wit­hin the manufacturer‘s facilities.