Oral Formulation Development–
The Altus Approach
The Altus team has designed and developed products on sale around the world in over 25 countries. Altus knows the rigorous standards for formulation and product development set by regulatory authorities like FDA, EMA, Health Canada and Anvisa to name a few.
Our team of experts employ the latest Quality by Design (QbD) and Design of Experiments (DoE) statistical approaches to ensure your product meets quality and performance requirements expected by the regulators and deserved by patients. Whether you need help to transition your drug through the entire development process or a solution for a specific issue, Altus Drug Development can help you achieve your goals. Our extensive knowledge and experience of oral solid dosage form development can shorten the development time and increase the value of your product.
Development Services based on Technology and Experience
Altus has a proven track record of developing new and Value-Added Medicines for our pharmaceutical company partners using a variety of solid dosage presentations including orally disintegrating tablets, solid dispersions, immediate release tablets and capsules, delayed release tablets and capsules, extended-release tablets and capsules and pulsatile release tablets and capsules. We combine years of experience with novel strategies, designs and patent protecting technologies to ensure your drug achieves its full commercial potential.
New Chemical Entity (NCE) and New Molecular Entity (NME) Development Services
Altus will design and develop novel and bespoke solid oral dose formulations to enable efficient preclinical/non-clinical testing and scale these to manufacture your GMP clinical supplies efficiently and cost-effectively. Altus will provide all development, stability and performance information you need for your IND or CTA. Our regulatory support services can manage all regulatory submissions.
For difficult to deliver drugs, Altus will use its patent protecting technologies including SmartCelle micellar technology and MicroSpheres+ immediate and modified release particles to enable efficient bioavailability-enhancing formulations for oral and intranasal drug delivery.
Value-Added Medicines Development
Repositioning and repurposing of well established, commercially available drugs via the US 505(b)(2), the European 10(3) Hybrid and Canadian SRTD regulatory pathways is a growing trend as the cost of new drug development increases. Many of these repurposed drugs lack patent protection.
Altus will use its patent protecting delivery technologies to design, formulate and develop differentiated, yet cost-effective new products, with extended patent protection in North America, Europe and Latin America. Altus’s new formulations provide value, and exclusivity in the market place.
Complex Generics Experience
Complex generic products earned their name because they have complex active ingredients, complex dosage forms or complex routes of administration. Complex generics include novel extended release products, novel abuse resistant products and multi-API combination products all of which have been enabled by Altus Technologies. FDA is encouraging drug developers to take on these difficult to develop drugs in return for regulatory advantages during the development process and Altus can help. Speak to Altus about its Complex Generic development experience.
Our oral formulation development services
We offer formulation development solutions in a wide array of product forms covering the entire development process of new oral drugs. Our oral solid dosage forms include solid dispersions, multiparticulate formulations, solid tablets, breakable tablets, film coated tablets, and modified release tablets including delayed release, pulsatile release and extended release of one or more active ingredients (APIs).
Pre-Clinical Projects Formulation Development
The amount of lead compounds available for pre-clinical testing is often limited and produced in multiple small batches. It’s essential that preclinical studies are robust irrespective of the batch of API that is used. Your lead compounds may also differ in structure and physicochemical properties, yet must be compared in vivo using formulations that minimize these differences.
Altus will design, develop and characterize robust, drug-efficient, homogeneous formulations for primary pharmacology, secondary pharmacology and safety pharmacology testing of lead candidates and efficiently transition them to batch controlled formulations for clinical testing.
Clinical and commercial stage formulation development
We offer full clinical batch manufacturing capabilities from pilot batch manufacture to support first in human (FIH) and feasibility studies, through phase II, phase III and registration batch manufacture. Altus can also manage your clinical packaging and distribution needs.
Strong analytical services to assist your formulation
Our skilled and experienced analytical team provides full method development services (assay, impurity, forced degradation, dissolution USP Type I-III), method validation and stability testing along with bioanalytical development and validation solutions to support your clinical program.
The Challenge of Ophthalmic Drug Delivery
Even more difficult is delivering drugs into the eye to treat conditions like uveitis and AMD. Today treatments for AMD require damaging monthly injections into the eye in a hospital while some 35,000 uveitis patients in North America still go blind each year because of ineffective treatment delivery.
SmartCelle Ocular Penetrating Technology:
The Altus Solution to Ocular Drug Delivery
SmartCelle Ocular Drug Delivery Technology
SmartCelle micelles can deliver increased concentrations of your drug to the front middle and back of the eye after only topical delivery. Here’s how.
Take advantage of SmartCelle’s unique ocular delivery properties
Discover More About Formulation Development
Pre-Clinical Ophthalmic Models
What are ophthalmic formulations?
Ophthalmic or ocular formulations are specialized drug compositions specifically designed and constructed for delivery of drugs to the surface of the eye as an eye drop (a topical instillation), as an ointment or cream, or for injection into the eye as an intravitreal (IVT) injection. SmartCelle Ocular Penetration Technology, designed with Altus’s unique understanding of the complex structures of the human eye, enables all forms of ocular delivery.
SmartCelle Ocular Penetration Technology enables enhanced delivery of your drug after topical instillation for improved ocular bioavailability and the potential for long-lasting depot formulations after intravitreal (IVT) injection.
Why is there a need for ocular formulations?
The majority of the world’s population will suffer eye diseases at one time or another and, as populations age so their frequency and severity increase. Even in early life patients may suffer from refractive errors that cause poor sight including short-sightedness (myopia) or long sightedness (hypermetropia), astigmatism or cataracts. Patients may also suffer from eye infections such as pink eye (conjunctivitis) or uveitis where the inner eye becomes inflamed, or dry eye disease (keratoconjunctivitis sicca) which causes painful, swollen and itchy eyes. Age-Related Macular Degeneration (AMD), where inflammation occurs in the retina at the back of the eye, is suffered by over 200 million people globally and is the leading cause of blindness in those over 50.
What forms can ophthalmic formulations take?
Ophthalmic formulations may be a solution, an ointment, a suspension/emulsion, or an injection.
The form of ophthalmic formulation most favoured by patients is delivery directly to the cornea at the front of the eye (topical delivery or instillation) since it is a simple, painless and convenient way to deliver drugs. The drawbacks of topical delivery, however, are that much of the liquid applied to the eye is likely to be washed away by tears, by blinking and by nasolacrimal drainage (removal of drug through the tear ducts to the nose) which together reduce the amount of drug left on the eye to treat the condition.
Ophthalmic suspensions and emulsions, although still in the trial phase, are again intended to increase drug residence time on the eye. However, the amount of drug available for absorption from a suspension or emulsion is limited. The ability of SmartCelle Ocular Penetration Technology to retain drugs on the surface of the eye while also presenting it in a form that can be absorbed by the eye is unique.
For some indications, such as Age-Related Macular Degeneration (AMD), drugs are typically injected into the eye using a syringe needle, a procedure (an IVT injection) performed under anaesthetic. SmartCelle Ocular Penetration Technology may avoid the need for painful in-patient injections with its ability to deliver drugs to the back of the eye. Long-lasting IVT Injections are also possible using SmartCelle depot formulations.
Why is ophthalmic formulation development important?
What are the challenges of an ophthalmic formulation?
A pH that resembles that of tear fluids is best to limit irritation, but presents difficulties when it comes to keeping the drug stable
All drugs must be pH-balanced but this is especially true for ocular treatments, as they can cause irritation or inflammation to sensitive cornea. The eye’s natural pH level is 7.4, which may present a challenge to many APIs which are unstable under these conditions. Altus formulators will find the balance between generating well tolerated, stable formulations.
Who oversees the formulation industry?
The United States Food and Drug Agency (FDA) Sets the Standards
From the earliest formulations, to your demonstration batches, Altus builds quality throughout the development process ensuring you have the data you need for cost-effective R&D that the meets the high standards set by FDA and all other regulatory authorities.
Learn more about Altus Value Added Medicines