SPI Pharma has commissioned a full-fledged drug development & testing center in the garden city of Bangalore. The development center is housed in a 16,000 sq. ft. building with room for expansion. Initially, 12 people will staff this facility with provisions for adding scientists in the future.
IDC will utilize state-of-the-art formulation and analytical equipment to enable finished product development in various dosage forms. The new facility will enable the company to conduct stability studies as per ICH guidelines and include provisions for a cGMP pilot-manufacturing unit. The laboratory will function under Good Laboratory Practice (GLP) standards.
With the addition of this capability, SPI Pharma will be in a position to speed up customized drug development projects using several of its proprietary excipients and delivery platforms such as Pharmaburst, Pharmafreeze, Pharmagum, Pharmasperse, and Pharmachew. Major capabilities of IDC will be pre formulation studies, excipient compatibility studies, forced degradation studies on API's, analytical methods development and validation, stability, dissolution, particle size modification including granulation, chilsonation, and slugging & Microencapsulation including taste-masking.
SPI Pharma is a world wide leader in custom formulation solutions for pharmaceutical and nutraceutical manufacturers. By offering raw materials, processing capabilities, and advanced application technologies SPI has become a valued source for complete custom delivery systems. This provides a competitive advantage for the customers' formulations.
SPI Pharma is an associated British foods company, based in the U.K. and has annual sales in excess of US $12 billion. SPI Pharma has sales in over 55 countries, supplying leading multinational companies. This effort is well supported by six manufacturing sites in the Americas and in Europe, and a worldwide sales staff.
The broad product line includes excipients, antacid actives, and formulated systems. All products are produced under cGMP manufacturing guidelines suitable for pharmaceutical and nutraceutical applications. Some of the advanced applications include solid dosage formulation, viscous suspensions/blends, DC chewing gum, effervescent systems, chewable/quick-dissolve tablets and customized granulations.
The unique combination of raw materials, delivery platforms, and processing capabilities integrated by SPI Pharma, provides innovative delivery systems for the customers' formulations. SPI Pharma has gone through a significant metamorphosis in the last decade. Building on its strong rooted history in the development and application of Polyols for more than a century, it is now transforming itself rapidly into a major contributor to the pharmaceutical industry by becoming a broad-based "solutions provider."
SPI is using its years of know-how in the structure-property relationships of sugars and sugar alcohols to develop innovative excipients and excipient combinations. Some of the products introduced to the pharmaceutical markets worldwide are :
- Mannogem EZ - Highly porous spray-dried mannitol
- Advantose 100 - Highly compactable & soluble maltose
- Compressol S - Co-processed excipient system
In addition, SPI has a broad knowledge base that deals with the combination of various excipients and their impact on the functionality of certain finished dosages.
SPI is a market leader in the supply of antacid actives, not merely based on its market share but on its innovative approaches which focus on improving taste and mouth- feel while lowering total cost. Their innovative product range comprises of:
- Co-blends - Easy-to-use liquid blends with excep-tional stability, taste and cost savings
- Barcroft Premix ST - Co-spray-dried, directly compressible powder of aluminum, magnesium and polyols
- Barcroft CS90 - Highly compactable, spray-dried, smooth-tasting calcium
- Barcroft MS90 - The only spray-dried, highly compactable magnesium hydroxide in the market
Apart from Antacid Actives SPI also manufactures Drug Delivery Systems.
Most of their development scientists have been formulators in large pharmaceutical companies and clearly understand the needs of the industry. Based on this knowledge and experience, they have developed several innovative, easy-to-use, fully tested delivery platforms. Some of these are listed as beneath:
- Pharmaburst™ - The first unique, quick dissolve tablet excipient system
- Pharmafreeze™ - Patented, robust, lyophilized orally disintegrating tablet system
- Pharmagum™ - Unique DC chewing gum powder made under cGMP
- Pharmasperse™ - Dry powder suspension system - reconstitutable into a syrup
DRUG DEVELOPMENT SERVICES:
Recently, SPI has expanded, through investments and exclusive partnerships, its capabilities to provide the pharmaceutical industry a research and development service in the drug development and commercialization market.
Some of these services are:
- Pharmasolutions - Develop drug formulations & methods, test stability & dissolution.
- Microencapsulation
- Provide customized taste masking and controlled-release of API's.
- Custom Processing - Granulation, micronizing, polymer coating, turn-key tableting and packaging.
SPI has broadened its capabilities to provide a wide range of cost effective solutions. This includes functional ingredients to easy-to-use delivery platforms to drug development and testing services.
SPI Pharma is dedicated to help global pharmaceutical companies achieve differentiation and speed-to-market. All of this under a flexible "pay-for-success" business model that is customized to specific needs. In India the agent - distributor for SPI Pharma is Indchem International, Mumbai.