I.Formulation Development
We have very experienced formulation scientists and Pharmacists who can develop dosage forms from simple to highly complex in nature for therapeutic or cosmetics purposes. We understand that each formulation development project is unique and have specific set of challenges associated like physical or chemical instability, poor solubility, low bioavailability, low targeting efficiency and others. We approach each unique project with maximum attention exploring multiple formulation options too as necessary for our customers. We really appreciate and understand the urgency of companies and timeline limitations and we always explore all the possible ways to complete the each project within the specified time.
We can help our customers in developing wide range of formulations like
1.Solid orals (conventional and controlled release)
(i) We develop and evaluate conventional and controlled release oral dosage forms for preclinical and early human studies
(ii) We develop nano-emulsion formulations which are prepared by high shear/speed homogenization and can be incorporated into suitable dosage forms as per the requirements
(iii) We develop nanoparticle formulations which are prepared by bead-milling or microfluidization, or homogenization and/ or ultrasonication and then incorporated into suitable dosage forms as per the requirements
(iv) We develop liposomes which are prepared by thin film hydration technique and reverse phase evaporation technique
(v) We develop controlled-release formulations which can provide sustained release with pH-independence, enteric protection and targeting colon
2.Parenterals (solutions, emulsions and nanoformulations)
We develop parenteral formulations suitable for the administration through intravenous, intramuscular and subcutaneous route
(i) We develop parenteral formulations with utmost attention and care having all requirements for sterile and pyrogen-free dosage form
(ii) We use best possible formulation techniques such as pH adjustments, co-solvents, complexation, surfactants and others for successful formulation development
(iii) We develop nano-emulsion formulations which are prepared by high shear/speed homogenization and nanoparticle formulations which are prepared by bead-milling or microfluidization, or homogenization and/ or ultrasonication for parenteral administration with maximum care and efficiency
(iv) We develop liposomes for parenteral use which are prepared by thin film hydration technique and reverse phase evaporation technique
3.Topical
We develop all categories of topical formulations for cosmetics and therapeutic applications
(i) We have high expertise in development of cosmetics formulations such as creams, lotion, serum, cleansers, moisturizers, gels, shampoos, face masks, hair styling products, conditioners, toners, skin lighteners, sun care products, and others using approved ingredients
(ii) We have huge expertise in developing topical conventional and controlled release creams, ointments, gels and sprays for muscle pain medication and numerous other diseases
II.Preformulation
Preformulation studies are among the significant preliminary steps in pharmaceutical development of a drug substance into various dosage forms. The physical and chemical properties of the drug substance (s) alone and in combination with excipients are investigated and critical properties are identified in this study. Preformulation studies help in several decisions making in formulation development of the drug product and provide a strong foundation for development of a dosage form that is highly robust during processing and storage conditions
(i) We study the drug candidate by evaluating its solubility profile, physical and chemical stability, and potential salt forms; and identifies impurities and degradation pathways
(ii) We characterize of the drug to determine thermal properties (melting point and glass transition), dissociation constant (pKa), particle size and morphology, partition coefficient (Log P)
(iii) We determine BCS classification, crystallinity (X-ray diffraction), solubility in various organic and aqueous solvents (in buffered systems), excipient compatibility (DSC and IR), and forced degradation (heat,light, acid, alkali,peroxides and metal ions)
III.Analytical Development
Accurate and precise analytical methods are integral part in the development of formulations. The design attributes of the developed formulations can be measured accurately by validated analytical methods. Development and validation of simple, sensitive, precise and inexpensive analytical methods suitable for routine use, are highly essential for the determination of drug in bulk, preformulation studies, formulations, in-vitro drug release samples, stability study, and in-vivo pharmacokinetic studies.
(i) We develop and validate (as per ICH and USP guidelines) analytical methods for our customers
(ii) Our expert analytical scientists deal with UV spectrophotometry, HPLC (all detectors), UPLC, GC LC MS for finished formulations and Drug substance
IV. Preclinical studies
The efficacy of formulations are investigated in appropriate animal models before performing the clinical studies in humans. This early preclinical studies serve as a useful tool for selecting most efficacious formulation with maximum safety as compared to standard drug available in market. This can provide a clear picture of drug action in vivo before proceeding with expensive human studies.
(i) We develop bioanalytical methods using HPLC and carry out pharmacokinetics and biodistribution studies in animal models (mice and S.D rats)
(ii) We develop in vivo animal models and study the efficiency of formulation as compared to standard drug available in market (mice, S.D rats, guinea pigs and rabbits)
(iii) We perform safety studies of API/Formulations in animal models
(iv) All studies are performed under the strict supervision of veterinary practitioner following stringent guidelines of CPSCEA
To know more information and collaboration possibilities, please email us to enquiry@ebrilive.com.